Permanent call for expression of interest

Transcription

1 2 September 2015 EMA/471207/2015 Administration Division 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 Table of contents 1. Contract Agent (FGIII), System Administrator - Virtual Communication, for Information Management Division (I) Keywords: Virtual communication, Software training, Multimedia, Virtual meeting technologies, Videoconference, Statistical control procedures General objectives: Specific objectives: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for admission: Contract Agent (FGIV), Java developer, for Information Management Division (I) Keywords: Java, Oracle, XML, OC4J, Ajax, Weblogic, J2EE, Visual Basic, CMS, Flex, PDF,BI General objectives: Elements that will be taken into account in determining candidates to be invited for interview: Experience and background in the following areas would be an advantage: Essential requirements for this post: Contract Agent (FGIV), Filemaker developer, for Applications Development & Maintenance service in Information Management Division (I) Keywords: Filemaker, Oracle, XML General objectives: Elements that will be taken into account in determining candidates to be invited for interview: Experience and background in the following areas would be an advantage: Essential requirements for this post: Contract Agent (FGIII), Filemaker developer for Applications Development & Maintenance service in Information Management Division (I) Keywords: Filemaker, Oracle, XML General objectives: Elements that will be taken into account in determining candidates to be invited for interview: Experience and background in the following areas would be an advantage: Essential requirements for the post: Contract Agent (FG IV), Project Management Service, Information Management Division (I) Keywords: project management, information technology In particular, the successful candidate is expected to carry out the following tasks: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for this post: Contract Agent (FG IV), System Analyst, Software Development Section, Information Management Division (I) Keywords: Analyst, Use Case, Requirement, User Stories, RUP, Agile EMA/471207/2015 Page 2/79

3 General objectives: Specific objectives: Elements which will be taken into account for invitation to interview: Successful candidates: Essential requirements for this post: Contract Agent (FG IV), Software Architect/Technical Lead, Software Development Section, Information Management Division (I) Keywords: Software Architect, Technical Lead, RUP, Agile, Java, Data Warehouse, Oracle, SAP General objectives: Specific objectives: Elements that will be taken into consideration for invitation to interview: Essential requirements for this post: Contract Agent (FG IV), IT Security Administrator, IT Operations, Information Management Division (I) Keywords: ISO27000, PKI, SECURITY, NETWORK, VPN, FIREWALL, RISK, IAM In Particular, the successful candidate is expected to carry out the following tasks: Elements that will be taken into account in determining candidates to be invited for interview: Essentials requirements for this post: Contract Agent (FGIII), Records Management Officer for the Data and Information Lifecycle service in the Information Management Division (I) Keywords: document management, records management, content management, communication, business processes In Particular, the successful candidate is expected to carry out the following tasks: Successful candidates are likely to have the following qualifications and background experience in the following areas: Essential requirements for admission: Contract Agent (FGIV), Data Manager for the Data and Information Lifecycle Management service in the Information Management Division (I) Keywords: Product Data Management, Administrative support, Procedures, Development of databases and information systems, Document and records management General objectives: Successful candidates are likely to have the following qualifications and background experience in the following areas: Essential requirements for admission: Contract Agent (FGIV), System Administrator - Virtual Communication for Applications & Platform Services in Information Management Division (I) Keywords: Virtual communication, Software training, Multimedia, Virtual meeting technologies, Videoconference, Statistical control procedures General objectives: Specific objectives: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for admission: EMA/471207/2015 Page 3/79

4 12. Contract Agent (FGIV), Java developer for Applications & Platform Services in Information Management Division (I) Keywords: Java, Oracle, XML, OC4J, Ajax, Weblogic, J2EE, Visual Basic, CMS General objectives: Elements that will be taken into account in determining candidates to be invited for interview: Experience and background in the following areas would be an advantage: Essential requirements for this post: Contract Agent (FGIV), Filemaker developer for Applications Development & Maintenance service in Information Management Division (I) Keywords: Filemaker, Oracle, XML General objectives: Elements that will be taken into account in determining candidates to be invited for interview: Experience and background in the following areas would be an advantage: Essential requirements for this post: Contract Agent (FGIII), Filemaker developer for Applications Development & Maintenance service in Information Management Division (I) Keywords: Filemaker, Oracle, XML General objectives: Elements that will be taken into account in determining candidates to be invited for interview: Experience and background in the following areas would be an advantage: Essential requirements for the post: Contract Agent (FGIII), Project Manager Assistant for Project Management service in the Information Management Division (I) Keywords: ITSM, ITIL, ISO/IEC 20000, VDI In particular, the successful candidate is expected to carry out the following tasks: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for the post: Contract Agent (FGIV), Business Analyst for Business Analysis service in the Information Management Division (I) Keywords: Analyst, Use Case, Requirement, User Stories, RUP, Agile, business process, business case, functional specification, BPMN, transformation programme In particular, the successful candidate is expected to carry out the following tasks: Elements which will be taken into account for invitation to interview: Successful candidates: Essential requirements for this post: Contract Agent (FGIV), ETL Developer for Data Modelling & Warehouse service in the Information Management Division (I) Keywords: ETL process, Oracle SQL, PL SQL, data modelling, data warehouse In particular, the successful candidate is expected to carry out the following tasks: Elements which will be taken into account for invitation to interview: Essential requirements for this post: EMA/471207/2015 Page 4/79

5 18. Contract Agent (FGIV), Data Architect for Data Modelling & Warehouse service in the Information Management Division (I) Keywords: design, data architecture, data quality, data analysis, ETL, PL SQL In particular, the successful candidate is expected to carry out the following tasks: Elements which will be taken into account for invitation to interview: Essential requirements for this post: Contract Agent (FGIV), Solution Architect/Technical Lead for Solution Design & Development service in the Information Management Division (I) Keywords: Software Architect, Solution Architect, Technical Lead, RUP, Agile, Java, Data Warehouse, Oracle, SAP In particular, the successful candidate is expected to carry out the following tasks: Elements that will be taken into consideration for invitation to interview: Essential requirements for this post: Contract Agent (FGIV), Stakeholders and Communication Division (S) Keywords: Stakeholders, patients, consumers, healthcare professionals, learned societies, pharmaceutical industry General objectives: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for admission: Contract Agent (FGIV), Communication Department, Stakeholders and Communication Division (S) Keywords: medical writing, communication, general public, web editing, media monitoring, press In particular, the successful candidate is expected to carry out the following tasks: Elements that will be taken into account in determining candidates to be invited for test/ interview: Elements that will be part of the test/ interview: Experience and knowledge in some of the following areas would be an additional advantage: Essential requirement for this post: Contract Agent (FGIV), Stakeholders and Communication Division (S) Keywords: Stakeholders, patients, consumers, healthcare professionals, learned societies, pharmaceutical industry In particular, the successful candidate is expected to carry out the following tasks: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for admission: Contract Agent (FGIV), Communication Department, for Stakeholders and Communication Division (S) Keywords: medical writing, communication, general public, web editing, media monitoring, press In particular, the successful candidate is expected to carry out the following tasks: Elements that will be taken into account in determining candidates to be invited for test/ interview: Elements that will be part of the test/ interview: EMA/471207/2015 Page 5/79

6 Experience and knowledge in some of the following areas would be an additional advantage: Essential requirement for this post: Contract Agent (FGIV), Web Content Project Manager, Online and Corporate Design Service, Communication Department, Stakeholders and Communication Division (S) Keywords: content development, content management, communication, web editing, web writing, information architecture In particular, the successful candidate is expected to carry out the following tasks: Elements that will be taken into account in determining candidates to be invited for test/ interview: Elements that will be part of the test / interview: Experience and knowledge in some of the following areas would be an additional advantage: Essential requirement for this post: Contract Agent (FGIV), Access to document Manager for the Access to Document service in the Stakeholders and Communication Division (S) Keywords: access to document, transparency, redaction In particular, the successful candidate is expected to carry out the following tasks: Successful candidates are likely to have the following qualifications and background experience in the following areas: Essential requirements for admission: Contract Agent (FGIV), Paediatrics, Human Medicines Development and Evaluation Division (D) Keywords: Medicine, Paediatric, Neonatology, Statistics, Clinical trials, Clinical and Nonclinical drug development, Toxicology, Pharmacology In particular, the successful candidate is expected to carry out the following tasks: Elements in the background of the candidates that will be taken into account in determining those to be invited for interview: Experience and knowledge in the following areas would be an additional advantage: Essential requirements for admission: Contract Agent (FGIV), Environmental Risk Assessment (ERA) Officer, Human Medicines Evaluation Division (E) Key words: environmental risk assessment (ERA), non-clinical development, pharmacology, toxicology, pharmacokinetics, metabolism, bioaccumulation, 3Rs Successful candidates are likely to have one or more of the following elements in their background: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for admission: Contract Agent (FGIV), Risk Management Specialist, Scientific and Regulatory Management Department, Human Medicines Evaluation Division (E) Key words: Risk Management, Data analysis, Adverse drug reaction reporting, Statistics, Epidemiology, Pharmacoepidemiology Successful candidates are likely to have one or more of the following elements in their background: EMA/471207/2015 Page 6/79

7 Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for admission: Contract Agent (FGIV), Scientific and Regulatory Management Department,, EMA Product Lead Human Medicines Evaluation Division (E) Keywords: Infectious diseases, Influenza, HIV, Vaccines, Tropical diseases, Central Nervous System, Ophthalmology, Diabetes, Endocrinology, Cardiovascular diseases, Diabetes, Oncology, Rheumatology, Gastroenterology, Pulmonology, Clinical Immunology, Internal Medicine Successful candidates are likely to have one or more of the following elements in their background: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for admission: Contract Agent (FGIV), Quality of Medicines for Chemical and Biological Medicinal Products, Human Medicines Evaluation Division (E) Keywords: Pharmacy, Quality (also: Chemical, Synthesis, Manufacturing, Generic, Biological, Vaccine, Blood Product, Advanced therapies) In particular, the successful candidate is expected to carry out the following tasks: This work will involve interactions with: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for admission: Contract Agent (FGIV), Labelling Specialist, Scientific and Regulatory Management Department, Human Medicines Evaluation Division (E) Keywords: Product information, Labelling review, Medication errors, Name review, Packaging review, Quality Review of Documents, User Testing General objectives: Successful candidates are likely to have one or more of the following elements in their background: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for this post are: Contract Agent (FGIV), Clinical Pharmacology, for Human Medicines Development and Evaluation Division (E) Keywords: Clinical Pharmacology (also: pharmacokinetics, pharmacodynamics, pharmacogenomics, biomarkers, bioequivalence, dose-finding, extrapolation) In particular, the successful candidate is expected to carry out the following tasks: This work will involve interactions with: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for admission: Contract Agent (FGIV), Veterinary Medicines Sector, Veterinary Medicines and Product Data Management Unit (V) Keywords: Authorisation of veterinary medicinal products, Establishment of Maximum Residue Limits, Scientific, technical and administrative support EMA/471207/2015 Page 7/79

8 Successful candidates are likely to have one or more of the following elements in their background: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for this post: Contract Agent (FGIV), Compliance and Inspection Department (P) Keywords: Medicine, Pharmacy, Manufacturing, Quality, Inspector, Inspection, Audit, Compliance, Scientific committees, Clinical, Monitor, CRA, Non-clinical, Pharmacovigilance, Parallel distribution, Statistics, Database, Testing Successful candidates are likely to have more than one of the following elements in their background: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for this post: Contract Agent (FGIV), Procedure Manager, Evaluation Procedures A-F services in Procedure Management department, Procedure Management and Business Support Division (C) Keywords: marketing authorisation, referrals, regulatory, risk, safety In particular, the successful candidate is expected to carry out the following tasks: Successful candidates are likely to have the following qualifications and background experience in the following areas: Essential requirements for admission: Contract Agent (FGIV), Data Scientist, Data Collection and Management service, Procedure Management and Business Support Division (C) Keywords: Data analysis, data management, data validation, SAS General objectives: Successful candidates are likely to have the following qualifications and background experience in the following areas: Essential requirements for admission: Contract Agent, Access to document Manager, Access to Document service, Procedure Management and Business Support Division (C) Keywords: access to document, transparency, redaction General objectives: Successful candidates are likely to have the following qualifications and background experience in the following areas: Essential requirements for admission: Contract Agent (FGIV), Committees Secretariat, Scientific Committee Support Department, Procedure Management & Committee Support Division (C) Keywords: Scientific Committee support, Community legislation, Centralised procedure, Mutual recognition procedure, Referral procedure General objectives: Successful candidates are likely to have the following qualifications and background experience in the following areas: Essential requirements for admission: EMA/471207/2015 Page 8/79

9 For the first essential requirement it will be necessary to provide proof at the interview stage Contract Agent (FGIV), Legal Department Keywords: Legal, legal advice, pharmaceutical law, Staff Regulations, access to documents, EU procurement law, anti-fraud General objectives: Elements that will be taken into account in determining candidates to be invited for interview: Essential requirements for this post: Contract Agent (FGIV), Communications Team, Office of the Executive Director Keywords: Press office, Media, Drafting, Editing, Journalism, Public Relations General objectives: Successful candidates are likely to have proven work experience in the following areas: Essential requirements for this post: EMA/471207/2015 Page 9/79

10 1. Contract Agent (FGIII), System Administrator - Virtual Communication, for Information Management Division (I) Keywords: Virtual communication, Software training, Multimedia, Virtual meeting technologies, Videoconference, Statistical control procedures. With responsibility, under the Head of Service for the design, definition, implementation, administration, operation, maintenance and evaluation of EMA s virtual communication scenarios from a user perspective, especially in the area of Virtual and Multimedia recorded/broadcasted meeting and e-learning. General objectives: Participate in the management, coordination and maintenance of all aspects of the EMA s virtual communication scenarios, especially Virtual and Multimedia recorded/broadcasted meetings; Participate in the overall design, building process and evolvement of EMA s virtual communication scenarios, especially Virtual and Multimedia recorded/broadcasted meeting; Planning and implementation of statistical control procedures; Planning and development of net based software training; Planning and implementation of unified communications solutions for EMA staff members in collaboration with Administration and Personnel; Coordinate tasks with all technical IT Teams. Specific objectives: Responsibility to support the testing and deployment of EMA s Virtual communication solutions, including key aspects of Videoconferencing and meeting dynamics from a user perspective; Responsibility for problem analysis, solution design, installation of new tools and general maintenance of the virtual communication environment; Responsibility for the quality control regarding all virtual communication scenarios; implemented at the EMA (includes statistical evaluation processes and comparative studies) Participating in other EMA IT projects. Elements that will be taken into account in determining candidates to be invited for interview: Good statistical knowledge and interpersonal skills; Good understanding of the key business, user and psychological challenges associated with virtual communication; Administration and behaviour of users in meetings; Identification and implementation of virtual meeting improvements; Virtual meeting technologies and Videoconference; EMA/471207/2015 Page 10/79

11 Statistical data evaluation/quality control; Experience in e-learning. Essential requirements for admission: A university degree in knowledge and or behavioural communications with computer science skills, with focus on virtual communication scenarios; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 11/79

12 2. Contract Agent (FGIV), Java developer, for Information Management Division (I) Keywords: Java, Oracle, XML, OC4J, Ajax, Weblogic, J2EE, Visual Basic, CMS, Flex, PDF,BI. Reporting to the Head of Service for Application Support. General objectives: Maintenance of Java applications; Optimising Oracle SQL queries; Problem diagnosis; Design, definition, implementation and maintenance of range of IT applications. Elements that will be taken into account in determining candidates to be invited for interview: Experience of developing 3-tier, Oracle based applications; Experience of developing Java Applications; Full life cycle development experience; Gathering user requirements; Developing prototypes; Writing, maintaining and testing programs; Deploying applications; Producing technical documentation; Assisting in user training and support; The candidate will be expected to work independently, to liaise effectively with teams and to have overall good interpersonal skills; Experience of working in a multicultural environment. Experience and background in the following areas would be an advantage: Knowledge of XML Weblogic 11g or Higher Oracle BI SAP Visual Basic and VBA Content Management Systems (CMS) EMA/471207/2015 Page 12/79

13 Web Services Data exchange and integration across applications using EAI Concepts Essential requirements for this post: A university degree in the field of IT, Sciences or Engineering; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 13/79

14 3. Contract Agent (FGIV), Filemaker developer, for Applications Development & Maintenance service in Information Management Division (I) Keywords: Filemaker, Oracle, XML. Reporting to the Head of Service for Application Support. General objectives: Maintenance of a range of Filemaker applications; Optimising Filemaker to Oracle SQL queries; Problem diagnosis and bug fixing; Design, definition, implementation and maintenance of enhancements to existing applications. Elements that will be taken into account in determining candidates to be invited for interview: Experience of developing (Oracle based) Filemaker applications; Full life cycle development experience; Gathering user requirements; Developing prototypes; Writing, maintaining and testing programs; Deploying applications; Producing technical documentation; Assisting in user training and support; The candidate will be expected to work independently, to liaise effectively with teams and to have overall good interpersonal skills; Experience of working in a multicultural environment. Experience and background in the following areas would be an advantage: Knowledge of XML Oracle database Essential requirements for this post: A university degree in the field of IT, Sciences or Engineering; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 14/79

15 4. Contract Agent (FGIII), Filemaker developer for Applications Development & Maintenance service in Information Management Division (I) Keywords: Filemaker, Oracle, XML. Reporting to the Head of Applications Development & Maintenance. General objectives: Maintenance of a range of Filemaker applications; Optimising Filemaker to Oracle SQL queries; Problem diagnosis and bug fixing; Design, definition, implementation and maintenance of enhancements to existing applications. Elements that will be taken into account in determining candidates to be invited for interview: Experience of developing (Oracle based) Filemaker applications; Full life cycle development experience; Gathering user requirements; Developing prototypes; Writing, maintaining and testing programs; Deploying applications; Producing technical documentation; Assisting in user training and support; The candidate will be expected to work independently, to liaise effectively with teams and to have overall good interpersonal skills; Experience of working in a multicultural environment. Experience and background in the following areas would be an advantage: Knowledge of XML Oracle database Essential requirements for the post: A post-secondary education diploma, plus three years professional experience or A secondary education certificate giving access to post-secondary education plus three years professional experience (which is the equivalent of the educational requirement mentioned at 1. above), plus a further three years experience making a total of six years professional experience; EMA/471207/2015 Page 15/79

16 A good command of English and a thorough knowledge of another official language of the European Union. EMA/471207/2015 Page 16/79

17 5. Contract Agent (FG IV), Project Management Service, Information Management Division (I) Keywords: project management, information technology. Reporting to the Head of Project Management, the Contract Agent will be responsible for the analysis, design, definition, prototyping, construction, implementation, operation and maintenance of assigned projects. In particular, the successful candidate is expected to carry out the following tasks: Project management including: proposals for project strategies, planning, definition of tasks and deliverables, review of project deliverables, quality control, risk analysis and management, status reports, problem reporting and management systems, follow up and organisation; estimation of costs, timescales and resource requirements for the successful completion of each project to agreed terms of reference; resource planning and allocation within the project; preparation and maintenance of project and quality plans and tracking of activities against the plan; provision of regular and accurate reports; monitoring of costs, timescales and resources used, and taking action where these deviate from agreed tolerances. Ensuring that delivered systems are implemented within these criteria; Applying the above to the execution of assigned projects and direct support to the Programme Managers for planning. Elements that will be taken into account in determining candidates to be invited for interview: Experience in working in a multilingual environment; Independency in carrying out work at the agency; Experience in Project Management in the context on delivering of Information Technology systems; Experience of active use of Project Management methodologies (i.e. Prince2 and RUP); Experience in implementing ITSM Projects based on ITIL best practise and/or ISO/IEC requirements; Experience in implementing VDI projects across departments. Essential requirements for this post: A university degree EMA/471207/2015 Page 17/79

18 A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 18/79

19 6. Contract Agent (FG IV), System Analyst, Software Development Section, Information Management Division (I) Keywords: Analyst, Use Case, Requirement, User Stories, RUP, Agile. With general responsibility, under the Head of Service for Software Development, the role involves gathering and analysing the business requirements from stakeholders through to specification of the detailed software requirements for development and testing of solutions within the European Medicines Agency. General objectives: Foster a shared understanding of the problems and solutions between the business and development communities; Record and communicate the system requirements to enable solutions to be developed and tested within agreed timescales ; Advise, support and promote best practise and improvements in the analysis and requirements gathering process within the Agency. Specific objectives: Gathering stakeholder requests Requirements management following a requirements management plan Analysis of requirements Business process Logical model Use cases Non-functional requirements Storyboarding/User interface Quality assurance/approval of relevant artefacts Issue management Support of project estimation and planning Support the yearly project planning exercise of the Agency Support testing and roll-out to the business community Management Reporting Elements which will be taken into account for invitation to interview: Expertise in: Requirements gathering from Business Experts; EMA/471207/2015 Page 19/79

20 Business Process Modelling; IBM Rational Unified Process; Iterative Software Development; Data Modelling; Use Case Specification; UML. Successful candidates: Should be adaptable and flexible; Have excellent communication skills at all levels; Be self-motivated and independent; Have excellent organisational skills. Essential requirements for this post: A university degree in the field of information technology; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 20/79

21 7. Contract Agent (FG IV), Software Architect/Technical Lead, Software Development Section, Information Management Division (I) Keywords: Software Architect, Technical Lead, RUP, Agile, Java, Data Warehouse, Oracle, SAP. With general responsibility, under the Head of Service for Software and Infrastructure Development, for information technology projects, principally developing systems serving the regulatory community in the European Union and the European Medicines Agency. General objectives: Advise and assist the Section Head of Service for Software and Infrastructure Development on the standardisation of the software and infrastructure development process in the European Medicines Agency; Monitor trends and developments in the IT industry and advise the Head of Service for Software and Infrastructure Development on if and how they affect the Agency s systems and/or its IT plans; Liaise with IT professionals from other institutions as required; Advise and assist the Head of Service for software and Infrastructure Development and other IT staff on any work related matter. Specific objectives: Design and implement information technology systems through appropriate user requirements and following an iterative software development process, alone or as software architect/technical lead of a team, when warranted by scale of project; Ensure proposed system specifications and technical solutions are coherent with the existing and envisaged software architecture at the European Medicines Agency and integrate with the existing systems; Moderate requests for updates on the ICT methodologies and standards and monitor their application across the developed technical solutions. Elements that will be taken into consideration for invitation to interview: Java web technologies; Oracle RDBMS and Data Warehouse solutions; SAP; Professional experience as a software architect/technical lead for at least a period of 12 months; Professional experience following an iterative software development process, e.g. Rational Unified Process; EMA/471207/2015 Page 21/79

22 Professional experience monitoring the application of information technology standards, adopted in an organisation, to software developed in house or outsourced; Experience of working in a multicultural environment. Essential requirements for this post: A university degree in the field of information technology; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 22/79

23 8. Contract Agent (FG IV), IT Security Administrator, IT Operations, Information Management Division (I) Keywords: ISO27000, PKI, SECURITY, NETWORK, VPN, FIREWALL, RISK, IAM. The person will be responsible for providing security administrator activities to the agency IT infrastructure. Under the direction of the IT-OPS Head of services, the IT Security Administrator will contribute to ensuring the necessary support of the monitoring, network and security systems of the Agency. In Particular, the successful candidate is expected to carry out the following tasks: Administration of Firewalls systems including management servers( Firewall, VPN gateways, SSLVPN systems; Administration of Proxy servers; Administration of endpoint security systems ( security gateways, management and log servers); Administration of the endpoint antivirus systems; Perform IT security monitoring and incident management tasks; Administration of internal and external PKI systems ( CA, HSM); Initiate, design, implement, monitor, audit and maintain IT security, risk and compliance technologies; Administration and support of the 2-factor authentication systems; Evaluating existing solutions and proposing risk mitigation solutions to enhance security and reduce risk exposure; Administration and support of vulnerability systems testing; Administration of Security Information and Event Management (SIEM) system; Take on additional tasks as required in the interest of the division. Elements that will be taken into account in determining candidates to be invited for interview: Experience in administering security systems (Firewalls, VPN gateways, SSLVPN systems; Experience in Linux administration; Experience in PKI system administration; Very good knowledge in network systems and administration ( switch, routers); 3 years of professional experience acquired in positions related to the profile of the post; Knowledge in implementing Endpoint security controls and testing; Experience in IT security monitoring and incident management; EMA/471207/2015 Page 23/79

24 Experience in patch management and relevant process. Essentials requirements for this post: A university degree; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 24/79

25 9. Contract Agent (FGIII), Records Management Officer for the Data and Information Lifecycle service in the Information Management Division (I) Keywords: document management, records management, content management, communication, business processes. The contract Agent will report to the Head of Data and Information Lifecycle Management. In Particular, the successful candidate is expected to carry out the following tasks: Provide and co-ordinate business support for content management systems, especially (Document Records and Electronic Archives Management (DREAM); Contribute to the formulation of policies, procedures, standards and guidelines necessary that support the Agency Document Lifecycle Management (DLM); Participate to the implementation of a new digital repository in the Agency with associated document management processes and standards; Administer the business ownership of the DREAM including MMD (Managing Meeting Documents system): support users, encourage best use of the system(s) and report technical problems to IT; Evaluate and monitor Agency programmes and projects in the context of their DLM needs; Hold and/or participate in DREAM Key Users (DKU) meetings; Record and prioritise change requests for minor system releases; Update the DREAM micro site; Co-ordinate DREAM training in collaboration with internal trainer and external trainers where applicable; Promote effective use of DREAM and contribute to business process re-engineering to improve the processes, the use of data and quality of outcome where possible, as part of the aim for continuous improving of the use of application and processes within the content management area. Successful candidates are likely to have the following qualifications and background experience in the following areas: Proven experience in coordinating communication activities; Good understanding of the work of Pharmaceutical Industry and EU Institutions within the context of the EU medicines regulatory framework; Experience in document management, record keeping, information management or related area; Good general knowledge of information technologies; and Knowledge in project management, business process analysis. EMA/471207/2015 Page 25/79

26 Essential requirements for admission: A post-secondary education diploma, plus three years professional experience or A secondary education certificate giving access to post-secondary education plus three years professional experience (which is the equivalent of the educational requirement mentioned at 1. above), plus a further three years experience making a total of six years professional experience; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 26/79

27 10. Contract Agent (FGIV), Data Manager for the Data and Information Lifecycle Management service in the Information Management Division (I) Keywords: Product Data Management, Administrative support, Procedures, Development of databases and information systems, Document and records management. Reporting to the Head of Data and Information Lifecycle Management, the Contract Agent will contribute to public health protection and to the coordination of the evaluation of marketing authorisation applications. The Contract Agent to support the management and quality assurance of the data held by the Agency relating to medicinal products principally, but not exclusively, which is maintained in the Agency s core product and application tracking system SIAMED (=Model System for Computer-assisted Drug Registration). General objectives: Reviewing, analysing and validating data to ensure consistency, integrity and accuracy; Acquiring a full understanding of data flows and data management as well as data sharing between corporate databases and other databases in the EU; Undertaking accurate data analysis to support the tasks of the Agency and its scientific committees; Translating regulatory requirements and business needs into data management objectives and system requirements to further the development of the Agency s product and application tracking system in liaison with the Information and Communications Unit and in the context of the development of an overall Enterprise Information Architecture for the Agency. Successful candidates are likely to have the following qualifications and background experience in the following areas: Experience or knowledge in the evaluation of marketing authorisation applications for medicinal products in one or more of the following areas: pharmaceutical industry, regulatory authority, academia; Ability to network and interact effectively with colleagues and work as part of a team. Essential requirements for admission: A university degree in life sciences, medicine, or pharmacy; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 27/79

28 11. Contract Agent (FGIV), System Administrator - Virtual Communication for Applications & Platform Services in Information Management Division (I) Keywords: Virtual communication, Software training, Multimedia, Virtual meeting technologies, Videoconference, Statistical control procedures. With responsibility and reporting to the Head of Service, for the design, definition, implementation, administration, operation, maintenance and evaluation of EMA s virtual communication scenarios from a user s perspective, especially in the area of Virtual and Multimedia recorded/broadcasted meeting and e-learning. General objectives: Participate in the management, coordination and maintenance of all aspects of the EMA s virtual communication scenarios, especially Virtual and Multimedia recorded/broadcasted meetings; Participate in the overall design, building process and evolvement of EMA s virtual communication scenarios, especially Virtual and Multimedia recorded/broadcasted meeting; Planning and implementation of statistical control procedures; Planning and development of net based software training; Planning and implementation of e-learning solutions for EMA staff members in collaboration with Administration and Personnel; Coordinate tasks with IT Service Desk team. Specific objectives: Responsibility to support the testing and deployment of EMA s Virtual communication solutions, including key aspects of Videoconferencing and meeting dynamics from a user perspective; Responsibility for problem analysis, solution design, installation of new tools and general maintenance of the virtual communication environment; Responsibility for the quality control regarding all virtual communication scenarios implemented at the EMA (includes statistical evaluation processes and comparative studies); Participating in other EMA IT projects. Elements that will be taken into account in determining candidates to be invited for interview: Good statistical knowledge and interpersonal skills; Good understanding of the key business, user and psychological challenges associated with virtual communication; Administration and behaviour of users in meetings; Identification and implementation of virtual meeting improvements; EMA/471207/2015 Page 28/79

29 Virtual meeting technologies and Videoconference; Statistical data evaluation/quality control; Experience in e-learning. Essential requirements for admission: A university degree in knowledge and or behavioral communications with computer science skills, with focus on virtual communication scenarios; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 29/79

30 12. Contract Agent (FGIV), Java developer for Applications & Platform Services in Information Management Division (I) Keywords: Java, Oracle, XML, OC4J, Ajax, Weblogic, J2EE, Visual Basic, CMS. Reporting to the Head of Service. General objectives: Maintenance of Java applications; Optimising Oracle SQL queries; Problem diagnosis; Design, definition, implementation and maintenance of range of IT applications. Elements that will be taken into account in determining candidates to be invited for interview: Experience of developing 3-tier, Oracle based applications; Experience of developing Java Applications; Full life cycle development experience; Gathering user requirements; Developing prototypes; Writing, maintaining and testing programs; Deploying applications; Producing technical documentation; Assisting in user training and support; The candidate will be expected to work independently, to liaise effectively with teams and to have overall good interpersonal skills; Experience of working in a multicultural environment. Experience and background in the following areas would be an advantage: Knowledge of XML Weblogic 11g Oracle BI SAP Visual Basic and VBA Content Management Systems (CMS) EMA/471207/2015 Page 30/79

31 Web Services Data exchange and integration across applications Essential requirements for this post: A university degree in the field of IT, Sciences or Engineering; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 31/79

32 13. Contract Agent (FGIV), Filemaker developer for Applications Development & Maintenance service in Information Management Division (I) Keywords: Filemaker, Oracle, XML. Reporting to the Head of Applications Development & Maintenance. General objectives: Maintenance of a range of Filemaker applications; Optimising Filemaker to Oracle SQL queries; Problem diagnosis and bug fixing; Design, definition, implementation and maintenance of enhancements to existing applications. Elements that will be taken into account in determining candidates to be invited for interview: Experience of developing (Oracle based) Filemaker applications; Full life cycle development experience; Gathering user requirements; Developing prototypes; Writing, maintaining and testing programs; Deploying applications; Producing technical documentation; Assisting in user training and support; The candidate will be expected to work independently, to liaise effectively with teams and to have overall good interpersonal skills; Experience of working in a multicultural environment. Experience and background in the following areas would be an advantage: Knowledge of XML Oracle database Essential requirements for this post: A university degree in the field of IT, Sciences or Engineering; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 32/79

33 14. Contract Agent (FGIII), Filemaker developer for Applications Development & Maintenance service in Information Management Division (I) Keywords: Filemaker, Oracle, XML. Reporting to the Head of Applications Development & Maintenance. General objectives: Maintenance of a range of Filemaker applications; Optimising Filemaker to Oracle SQL queries; Problem diagnosis and bug fixing; Design, definition, implementation and maintenance of enhancements to existing applications. Elements that will be taken into account in determining candidates to be invited for interview: Experience of developing (Oracle based) Filemaker applications; Full life cycle development experience; Gathering user requirements; Developing prototypes; Writing, maintaining and testing programs; Deploying applications; Producing technical documentation; Assisting in user training and support; The candidate will be expected to work independently, to liaise effectively with teams and to have overall good interpersonal skills; Experience of working in a multicultural environment. Experience and background in the following areas would be an advantage: Knowledge of XML Oracle database Essential requirements for the post: A post-secondary education diploma, plus three years professional experience or A secondary education certificate giving access to post-secondary education plus three years professional experience (which is the equivalent of the educational requirement mentioned at 1. above), plus a further three years experience making a total of six years professional experience; EMA/471207/2015 Page 33/79

34 A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 34/79

35 15. Contract Agent (FGIII), Project Manager Assistant for Project Management service in the Information Management Division (I) Keywords: ITSM, ITIL, ISO/IEC 20000, VDI. Reporting to the Head of Project Management, the Contract Agent will be responsible for the analysis, design, definition, prototyping, construction, implementation, operation and maintenance of assigned projects. In particular, the successful candidate is expected to carry out the following tasks: Project management assistance in the form of: reporting on strategic direction, tasks, deliverables, quality control, risk analysis and management, issue management, organisational issues and status in general versus agreed terms of reference; documentation and information dissemination. Project management (primarily for smaller projects) including: proposals for project strategies, planning, definition of tasks and deliverables, review of project deliverables, quality control, risk analysis and management, status reports, problem reporting and management systems, follow up and organisation; estimation of costs, timescales and resource requirements for the successful completion of each project to agreed terms of reference; preparation and maintenance of project and quality plans and tracking of activities against the plan; provision of regular and accurate reports; monitoring of costs, timescales and resources used, and taking action where these deviate from agreed tolerances; ensuring that delivered systems are implemented within these criteria. Applying the above to the execution of assigned projects and direct support to the Programme Managers for planning Monitoring the execution of the sector s work programme Resource planning and allocation Elements that will be taken into account in determining candidates to be invited for interview: Experience in Project Management in the context of delivering of Information Technology systems Experience of active use of Project Management methodologies (i.e. Prince2 and RUP) Experience in working in a multilingual environment EMA/471207/2015 Page 35/79

36 Essential requirements for the post: A post-secondary education diploma, plus three years professional experience or A secondary education certificate giving access to post-secondary education plus three years professional experience (which is the equivalent of the educational requirement mentioned at 1. above), plus a further three years experience making a total of six years professional experience; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 36/79

37 16. Contract Agent (FGIV), Business Analyst for Business Analysis service in the Information Management Division (I) Keywords: Analyst, Use Case, Requirement, User Stories, RUP, Agile, business process, business case, functional specification, BPMN, transformation programme. Reporting to the Head of Business Analysis, the Contract Agent will be responsible for gathering and analysing the business requirements from stakeholders through to specification of the detailed software requirements for development and testing of solutions within the European Medicines Agency. In particular, the successful candidate is expected to carry out the following tasks: Help the Agency s core business, through the use of business process modelling and conceptual information modelling to understand the existing business structures and mechanisms; Contribute to the development of IT systems and be able to identify gaps or overlaps in functionality; Dealing with to-be processes, the successful candidate helps management in making strategic choices and is able to indicate the impact on people, organisation and systems; As a member of project team/s, perform requirement analysis with the stakeholders and translate these requirements into detailed specifications (including mock-ups, design of actors flow and data modelling); Write documentation on processes and context i.e. the different information elements and their relationships; As a member of the IT Delivery department, ensure that requirements are mapped to or driven from within the business processes and where relevant, programmes and projects are aligned with any business process improvements the Agency wants to achieve; Communicate with a variety of internal and external stakeholders (Management Board, Agency management, Agency staff etc.); Work with the IT Architects (incl. Enterprise Architects, Lead Data Architect, Application Architects etc.) to make sure the business concepts are covered in the overall architecture; Contribute to the improvement of business process mapping methodology and business analysis methodology; Lead and coach cross-agency project teams in business analysis and process analysis when required; Support any implementation programmes by inputting to or leading on the design of To-Be Processes; Build Agency-wide businesses processes in line with plans and where relevant ensure these integrate with organisational plans EMA/471207/2015 Page 37/79

38 Elements which will be taken into account for invitation to interview: Proven experience in business analysis and business process analysis for development of IT systems and their alignment to the business objectives. The candidates shall describe the details of the work they have produced during the last 5 projects including the deliverables, their content and what were the steps they have undertaken to deliver them; Experience of working on projects where a wide variety of stakeholders are involved demonstrating team building, proven inter-disciplinary approach, systematic approach combined with an orientation on results and pragmatism; Proven experience and responsibility to deliver business analysis deliverables: business requirements documentation, functional requirements, as-is processes, to-be processes, use cases and involvement in the business case of a project. The candidates shall describe the details of the work they have produced during the last 5 projects including the deliverables, their content and what were the steps they have undertaken to deliver them; Proven experience on user interface design, prototyping decision tables/trees, data flows, fit/gap analysis, business rules analysis and process and system improvement in existing designs or new functionalities. The candidates shall describe the details of the work they have produced during the last 5 projects including the deliverables, their content and what were the steps they have undertaken to deliver them; Proven experience on planning and estimating work, presenting business cases, creating and conducting training and assisting in all phases of the lifecycle of the project would be advantageous. The candidates shall describe the details of the work they have produced during the last 5 projects including the deliverables, their content and what were the steps they have undertaken to deliver them; Knowledge and experience of the following would be advantageous: UML modelling; EU/international process modelling standards e.g. BPMN; Hands on experience with modelling software (Sparx EA, PowerDesigner, MEGA, ARIS); Enterprise Architecture frameworks, like TOGAF, MODAF, Zachman Frameworks etc.; System Engineering processes such as DOD, CMMI for Systems Engineering/Software or others. Successful candidates: Should be adaptable and flexible Have excellent communication skills at all levels Be self-motivated and independent Have excellent organisational skills Essential requirements for this post: A university degree in the field of Information Technology, Engineering, Computer Science or Economics; EMA/471207/2015 Page 38/79

39 A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 39/79

40 17. Contract Agent (FGIV), ETL Developer for Data Modelling & Warehouse service in the Information Management Division (I) Keywords: ETL process, Oracle SQL, PL SQL, data modelling, data warehouse. Reporting to the Head of Data Modelling & Warehouse, the Contract Agent will be responsible to design and develop processes to integrate data from various data stores into data warehouse/data marts, to design and develop data migration processes, design and develop data services to be consumed in various applications. In particular, the successful candidate is expected to carry out the following tasks: Design and develop ETL processes to load data from various sources into Data Warehouse/Data Marts with the scope of making data available for analysis and reporting using Oracle Data Integrator, PLSQL or any other data integration tools that the Agency will decide to use; Design and develop data services which will be used by various systems using Agency s tools for data integration; Design and develop data migration processes; Investigate data related issues; Performance improvements of ETL jobs or data services; The role will be under the supervision of Data Warehouse Architect and it will work closely with data architects, BI developers and business analysts. Elements which will be taken into account for invitation to interview: A minimum of 3 years IT professional experience within Oracle environment for Data Warehouse implementations (Oracle Database, OWB, ODI, OBIEE), including 2 years working as ETL Developer; Experience with development of Oracle SQL, PL SQL code; Experience of working with OWB and Informatica will be an advantage; Experience of implementing reporting solutions using OBIEE will be an advantage; Knowledge of XML, experience with defining complex XML Schemas and experience with generation xml schemas from databases; Experience of working with modelling tools (e.g. PowerDesigner; Sparx); Experience with designing Physical Data Models; Experience in SQL tuning, PL-SQL optimisation; Experience in data migration, application integration (information aspects), SOA, Master Data Management; EMA/471207/2015 Page 40/79

41 Experience in conducting workshops and eliciting requirements. Essential requirements for this post: A university degree in the field of Information Systems or Engineering, Computer Science; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 41/79

42 18. Contract Agent (FGIV), Data Architect for Data Modelling & Warehouse service in the Information Management Division (I) Keywords: design, data architecture, data quality, data analysis, ETL, PL SQL. Reporting to the Head of Data Modelling & Warehouse, the Contract Agent will be responsible to design the data architecture for applications within Master Data, Pharmacovigilance, Procedure Management for Human and Veterinary areas and Clinical Trials domains, assuring their interrelation with the chosen Enterprise Architecture. This is to uplift the function of data management, data quality, data analysis, and the sharing of data to the desired strategic level. In particular, the successful candidate is expected to carry out the following tasks: Help the Agency s core business, through the use of data modelling, to understand the existing data and information flows; Contribute in data needs or usage in the development of IT systems, and identify gaps or overlaps in functionality. Dealing with to-be processes, the successful candidate helps management in making strategic choices and is able to indicate the impact on people, organisation and systems; Work under the guidance of the Lead Data Architect with Business, IT Development and IT Infrastructure team of architects to realise coherent data architecture models both on enterprise as well as on project levels; Deliver the data artefacts needed (e.g. logical data model; physical data model; data movement model); Ensure that data is mapped to or driven from within the business processes and requirements and where relevant, programme and project data deliverables are aligned with any business process improvements the Agency wants to achieve; Communicating with a variety of internal and external stakeholders (Management Board, Agency management, Agency staff etc.); As a member of project team/s, performing requirement analysis with the stakeholders and translating these requirements into detailed specifications (including mock-ups, design of actors flow.); Contributing to the improvement of data mapping methodology and business analysis methodology; Ensure the data architecture at the levels at which he/she is working is in accordance with the chosen Enterprise architecture; Assist in the development of data architecture standards, policies and procedures for the organisation; Facilitate consistent standards and methods for process & business analysis, data exchange, data acquisition, data access, data analysis and design, archive and recovery strategy; EMA/471207/2015 Page 42/79

43 Contribute to the EMA IT data strategy (i.e. how the Agency manages data, turns the strategic value of data into public health positive outcomes.); Assist with the metadata management and repository strategy to manage all enterprise information architecture project artefacts; For the domains in which operating, ensure that existing data assets are identified, mapped and aligned to the Agency s strategy on data architecture; Understand regulatory issues (e.g. consumer privacy laws, outsourced data and specific industry guidelines) to assist in developing and maintaining internal and external checks and controls to ensure proper governance, security and quality of information assets; Assist in setting up the necessary data governance. Elements which will be taken into account for invitation to interview: A minimum of 3 years IT professional experience, including 1 year as a Data Architect dealing with large and complex database management systems, and an overall hands-on experience in application development; Proven experience with information modelling using different notations (e.g. Barker notation, UML); Knowledge of XML and experience with defining complex XML Schemas; Proven experience in designing conceptual data models, logical data models and physical data models for large and complex business domains; Experience of working with modelling tools (e.g. PowerDesigner; Sparx); Experience in data migration, application integration (information aspects), SOA, Master Data Management; Experience in conducting workshops and eliciting requirements; Experience and/or qualifications in System Engineering processes e.g. Agile, RUP standards and other development methodologies; Experience in application development for Healthcare or Pharmaceutical industry; Experience in handling Pharmaceutical or Healthcare related data; Experience of working within Enterprise Architecture frameworks, like TOGAF, Zachman Framework, etc.; Vision on the emerging technologies like NoSQL, Big Data, Open Data, etc. Essential requirements for this post: A university degree in the field of Information Systems or Engineering, Computer Science; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 43/79

44 19. Contract Agent (FGIV), Solution Architect/Technical Lead for Solution Design & Development service in the Information Management Division (I) Keywords: Software Architect, Solution Architect, Technical Lead, RUP, Agile, Java, Data Warehouse, Oracle, SAP. Reporting to the Head of Solution Design & Development, the Contract Agent will be responsible for information technology projects, principally developing systems serving the regulatory community in the European Union and the European Medicines Agency. In particular, the successful candidate is expected to carry out the following tasks: Design solutions complying with EMA s Enterprise Architecture standards; Communicate solution architecture and ensure it is sufficiently documented; Develop software according to defined requirements in compliance with agreed project planning and standards alone or leading a team as required by the scale of the solution; Propose end-to-end solution designs addressing business requirements; Conduct proof of concepts, validating the proposed solution meets the functional and nonfunctional requirements based on EMA s reference architecture; Lead the decision making process for the necessary solution architecture decisions and ensure they are justified and documented; Ensure functional and non-functional requirements, such as security and performance, are met by the system s architecture and liaise with the stakeholders where necessary; Assist project manager in defining and estimating work packages and allocating resources according to their skills for project work; Assist test management by identifying complex parts of the implementation; Plan go-live with release managers and operations and provide the necessary documentation Ensure the delivery of good quality software product by: Confirm the implementation of unit and integration testing of the system s key functional requirement by the development team Analysing and driving the resolution of issues raised by EMA s static code analysis software Clearly articulating tactical decisions taken during the course of the project and proposing corrective actions Liaise effectively with the relevant project teams and other business and IT stakeholders as required; Present solution architecture to Enterprise Architecture Board and address resulting actions; Perform architecture and code reviews for the duration of the project; EMA/471207/2015 Page 44/79

45 Implement software or lead the development effort, according to requirements and EMA s quality standards; Contribute in the process of updating EMA s reference architecture and IT standards when required; Advise and assist the Head of Service for Solution design and development on the standardisation of the software development process in the European Medicines Agency; Support software implementation according to defined requirements, in compliance with agreed project planning. Elements that will be taken into consideration for invitation to interview: At least three years professional experience in an IT Development role, including professional experience as a Solution Architect/Technical Lead relating to one or more of the fields in the above description of the duties; Proven professional experience in the following: Producing technical design documents Ability to challenge designs and requirements with the business in order to simplify solution and integration approach Ability to estimate design work to be brought to completion Professional experience in estimating implementation effort and defining work packages Professional experience in implementing solutions using: JEE technologies Service Oriented Architecture concepts Enterprise Integration design patterns Professional experience in performing code and architecture reviews of software developed inhouse or outsourced and accessing compliance with agreed standards; Professional experience following an iterative software development process, e.g. Agile or Rational Unified Process; Professional experience of setting standards and methods for a team; Ability to define end-to-end enterprise solution designs; Experience of working in a multicultural environment and or pharma sector; Prior professional experience in implementing solutions using: Case management and/or workflow solutions; (e.g. Oracle, BeInformed Informatica, Pegasystem); Portal solutions (e.g. Liferay, Alfresco); Document Management Systems (e.g. Documentum, Alfresco, IBM FileNet); would be an additional advantage. EMA/471207/2015 Page 45/79

46 Essential requirements for this post: A university degree in the field of Information Technology, Computer Science, Electronic Engineering or other field related to the description of tasks A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the interview stage. EMA/471207/2015 Page 46/79

47 20. Contract Agent (FGIV), Stakeholders and Communication Division (S) Keywords: Stakeholders, patients, consumers, healthcare professionals, learned societies, pharmaceutical industry. Reporting to the relevant Head of Department, Corporate Stakeholders Department or Patients and Healthcare Professionals Department. General objectives: Contributing to further development of the interaction with the stakeholders. In this context, stakeholders include patients, consumers and healthcare professionals organisations, learned societies and pharmaceutical industry; Organising stakeholders consultation, information and collaboration; Providing support to other Departments/Divisions with regard to the involvement of stakeholders in EMA activities; Contributing, implementing and adhering to Quality Assurance System of the EMEA including preparation of guidelines, SOP and templates. Elements that will be taken into account in determining candidates to be invited for interview: Scientific knowledge in healthcare field or life science; Understanding of Community Legislation in the field of pharmaceuticals; Previous experience in the pharmaceutical field and /or interaction with stakeholders; Working in a team environment. Essential requirements for admission: A university degree in the field of preferably medicine or pharmacy or life sciences; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 47/79

48 21. Contract Agent (FGIV), Communication Department, Stakeholders and Communication Division (S) Keywords: medical writing, communication, general public, web editing, media monitoring, press. In particular, the successful candidate is expected to carry out the following tasks: Writing health information on medicines in plain English for patients and the general public, as well as information material targeted to more specialised audiences including healthcare professionals; Developing key messages and talking points to be used by medicines regulatory authorities across Europe in order to respond to public queries or concerns related to medicines; Writing content for the Agency s website; Helping with media monitoring and early identification of topics that are of relevance for external communication; Editing and reviewing English-language documents prepared by other colleagues within the Agency; Ensuring consistency and clarity of documents written for the general public; Contributing to discussions on the Agency s communication plans and strategies on different topics and for different stakeholders (e.g. patients, healthcare professionals and the general public). Elements that will be taken into account in determining candidates to be invited for test/ interview: Professional experience in working in a science or health-related communication environment preparing written information for the public; Experience in writing in English, with the ability to translate complex, scientific information into a language that is understood by the specific target audience, such as healthcare professionals, patients or the general public; Professional experience in the areas stated above; Good understanding of medicines and health and the information needs of patients and the general public. Elements that will be part of the test/ interview: Excellent communication skills in English; Ability to communicate clearly while keeping strictly to the rules; Attention to detail and ability to work effectively within given timeframe; Excellent organisation skills; Initiative, diplomacy and good judgement; EMA/471207/2015 Page 48/79

49 Good interpersonal skills and team spirit. Experience and knowledge in some of the following areas would be an additional advantage: Writing content for the electronic media; Working as part of a multinational team; Understanding of European Union legislation in the field of pharmaceuticals. Essential requirement for this post: A university degree preferably in medicine, pharmacy, a life science, journalism or communications; Excellent command of English to the extent necessary for the performance of the duties and a thorough knowledge of another language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 49/79

50 22. Contract Agent (FGIV), Stakeholders and Communication Division (S) Keywords: Stakeholders, patients, consumers, healthcare professionals, learned societies, pharmaceutical industry. Reporting to the relevant Head of Department, Corporate Stakeholders Department or Patients and Healthcare Professionals Department. In particular, the successful candidate is expected to carry out the following tasks: Contributing to further development of the interaction with the stakeholders. In this context, stakeholders include patients, consumers and healthcare professionals organisations, learned societies and pharmaceutical industry; Organising stakeholders consultation, information and collaboration Providing support to other Departments/Divisions with regard to the involvement of stakeholders in EMA activities; Contributing, implementing and adhering to Quality Assurance System of the EMEA including preparation of guidelines, SOP and templates. Elements that will be taken into account in determining candidates to be invited for interview: Scientific knowledge in healthcare field or life science; Understanding of Community Legislation in the field of pharmaceuticals. Previous experience in the pharmaceutical field and /or interaction with stakeholders. Working in a team environment. Essential requirements for admission: A university degree in the field of preferably medicine or pharmacy or life sciences A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 50/79

51 23. Contract Agent (FGIV), Communication Department, for Stakeholders and Communication Division (S) Keywords: medical writing, communication, general public, web editing, media monitoring, press. Reporting to the Head of Communication Department. In particular, the successful candidate is expected to carry out the following tasks: Writing health information on medicines in plain English for patients and the general public, as well as information material targeted to more specialised audiences including healthcare professionals; Developing key messages and talking points to be used by medicines regulatory authorities across Europe in order to respond to public queries or concerns related to medicines; Writing content for the Agency s website; Helping with media monitoring and early identification of topics that are of relevance for external communication; Editing and reviewing English-language documents prepared by other colleagues within the Agency; Ensuring consistency and clarity of documents written for the general public; Contributing to discussions on the Agency s communication plans and strategies on different topics and for different stakeholders (e.g. patients, healthcare professionals and the general public). Elements that will be taken into account in determining candidates to be invited for test/ interview: Professional experience in working in a science or health-related communication environment preparing written information for the public; Experience in writing in English, with the ability to translate complex, scientific information into a language that is understood by the specific target audience, such as healthcare professionals, patients or the general public; Professional experience in the areas stated above; Good understanding of medicines and health and the information needs of patients and the general public. Elements that will be part of the test/ interview: Excellent communication skills in English; Ability to communicate clearly while keeping strictly to the rules; Attention to detail and ability to work effectively within given timeframe. Excellent organisation skills; EMA/471207/2015 Page 51/79

52 Initiative, diplomacy and good judgement; Good interpersonal skills and team spirit; Experience and knowledge in some of the following areas would be an additional advantage: Writing content for the electronic media; Working as part of a multinational team; Understanding of European Union legislation in the field of pharmaceuticals. Essential requirement for this post: A university degree preferably in medicine, pharmacy, a life science, journalism or communications; Excellent command of English to the extent necessary for the performance of the duties and a thorough knowledge of another language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 52/79

53 24. Contract Agent (FGIV), Web Content Project Manager, Online and Corporate Design Service, Communication Department, Stakeholders and Communication Division (S) Keywords: content development, content management, communication, web editing, web writing, information architecture. In particular, the successful candidate is expected to carry out the following tasks: As a content-management specialist, to provide advice, expertise and guidance to the Online Programme team on the best approach to web content development, implementation and maintenance; To continue to evolve editorial policies with EMA communications staff in line with best practice and to champion their use across EMA; To monitor progress and produce regular status reports; Specific objectives: To identify and interview content owners and other key business stakeholders as part of the Online Programme; To scope the content work to be delivered for the Online Programme; To develop a comprehensive plan of action for content-related work to be carried out for all websites to be developed as part of the Online Programme, including development of content strategies and resourcing plans as necessary. This will cover all stages of content development from content layout, navigation / information architecture, editing and uploading to the content management system, to verification. This will include, for example: Documenting stakeholder web-publication processes and current communications practices and requirements; Working with other Programme team members to contextualise these requirements against identified user needs and overall Programme and project objectives; Creating copywriting briefs for the development of new content. To lead content development work across the Online Programme, including overseeing the work of others as necessary. This work will include: Writing effective and engaging web copy against some or all of the copywriting briefs, ensuring that content is high-quality, accurate and accessible for EMA audience groups, and is prepared in liaison with content owners and other key stakeholders; Mapping and managing migration of content from the existing web content management system to the new publishing platform and liaising with information-technology teams to agree on the technical aspects of content migration; Assisting in the management of innovative methods for delivering the editorial aspects of multimedia projects, such as audio and video; To develop and apply taxonomy and metadata strategies in collaboration with the Data Management Department. EMA/471207/2015 Page 53/79

54 Elements that will be taken into account in determining candidates to be invited for test/ interview: Professional experience in working in a science or health-related communication environment preparing written information for the public; Excellent English web writing skills, with the ability to translate complex, scientific and regulatory information into appropriate language for key website user groups, such as regulatory affairs professionals, Agency staff, members of the Agency s scientific committees, healthcare professionals and patients; Professional experience in web content management, including content strategy and audit, planning, content development, migration, content maintenance, and managing taxonomies and metadata. Elements that will be part of the test / interview: Excellent communication skills in English, including editing, reviewing, approving and writing content for websites; Knowledge of industry best practice and of recognised web usability and accessibility standards; Ability to communicate clearly while keeping strictly to the rules; Attention to detail and ability to work effectively within a given timeframe; Excellent organisational skills; Initiative, diplomacy and good judgement; Good interpersonal skills and team spirit. Experience and knowledge in some of the following areas would be an additional advantage: Leadership / management of online editorial teams; Project management; Web content management system technologies; Working as part of a multinational team; Understanding of European Union legislation in the field of pharmaceuticals. Essential requirement for this post: a university degree preferably in medicine, pharmacy, a life science, journalism or communications; excellent command of English to the extent necessary for the performance of the duties and a thorough knowledge of another language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 54/79

55 25. Contract Agent (FGIV), Access to document Manager for the Access to Document service in the Stakeholders and Communication Division (S) Keywords: access to document, transparency, redaction. With responsibility under the Service Head for Access do Document (ATD), the Contract Agent will manage the most complicated requests to access documents: process and documents. The job holder will be responsible for clarifying requests, exchanging with all stakeholders involved, estimating workload, ensuring respect of legal timelines and preparation of documents in line with EMA redaction principles. Also responsible for escalating the request to access documents to the ATD Management Team for advice prior to a decision being taken by the EMA, and accountable for the process management of requests to access documents as per their assigned ATD portfolio. In particular, the successful candidate is expected to carry out the following tasks: Principal contact for requester and any third party involved in the ATD request; Ensuring that a request to access documents is clear and meets the regulatory criteria; Responsible for providing guidance to all stakeholders; Adherence to legal timelines; Estimating complexity, workload and release timelines for their assigned ATD requests; Assessing the need to bring the ATD request to the ATD meeting (ATDMT) for discussion or information prior to the EMA taking any decision; Ensuring that the correct documents have been identified to satisfy the need of the requester; Ensuring that all steps of the process are followed; Ensuring that the correct templates are used for the process and flagging any updates required; Ensuring that the documents have been correctly redacted according to the EMA redaction principles; Responsible for identifying legal issues and escalating them to the legal officer in charge of the ATD request; Responsible for managing any assistant who may have to help with complex ATD requests, defining tasks, timelines, providing guidance; Accountable for the accuracy of entries in the workflow tool and in the ATD tracking table; Accountable for the correct filing in DREAM; Responsible for preparing the redaction guidelines assigned to them. Successful candidates are likely to have the following qualifications and background experience in the following areas: Scientific understanding of pharmaceutical and safety/efficacy aspects of the submission; EMA/471207/2015 Page 55/79

56 Strong knowledge of regulatory aspects of procedures; Essential requirements for admission: A university degree in Pharmacy/Medicines or other life sciences; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 56/79

57 26. Contract Agent (FGIV), Paediatrics, Human Medicines Development and Evaluation Division (D) Keywords: Medicine, Paediatric, Neonatology, Statistics, Clinical trials, Clinical and Non-clinical drug development, Toxicology, Pharmacology. Reporting to the Section Head, Paediatric Medicines, of the Human Medicines Development and Evaluation Unit. In particular, the successful candidate is expected to carry out the following tasks: Managing the procedures of paediatric investigation plans; Providing scientific, technical and administrative support for projects involving the Agency s committees and groups of experts; Liaising with rapporteurs/peer reviewers and coordinating activities essential to the provision of objective scientific opinions and their formal adoption by the Paediatric Committee (PDCO). Elements in the background of the candidates that will be taken into account in determining those to be invited for interview: Medical training or other professional education in Paediatrics or Neonatology; Any medical training and good competence on methodology and statistics in clinical trials; Experience in non-clinical drug development (toxicology, pharmacology); Experience or a good understanding of clinical drug development. Experience and knowledge in the following areas would be an additional advantage: Qualified experience as an assessor in regulatory authorities or in Research & Development in Industry; General knowledge of Community institutions including the Agency and the pharmaceutical legal framework. Essential requirements for admission: A university degree in medicine or, alternatively, another health science degree together with good evidence of development in the competences mentioned above; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 57/79

58 27. Contract Agent (FGIV), Environmental Risk Assessment (ERA) Officer, Human Medicines Evaluation Division (E) Key words: environmental risk assessment (ERA), non-clinical development, pharmacology, toxicology, pharmacokinetics, metabolism, bioaccumulation, 3Rs. Reporting to the Head of the Clinical Pharmacology and Non-clinical Support Office in the Human Medicines Development and Evaluation Division, the Contract Agent would be responsible for providing scientific support for non-clinical and environmental risk assessment activities. These activities include but are not limited to: assessment of ERA-related issues of submitted dossiers as part of the medicines regulatory process; scientific support to the EMA network and the Agency s committees and working parties on non-clinical matters along the medicinal product life-cycle; scientific contribution to medicinal products and guidelines in particular for the area of ERA including liaising with veterinary medicines colleagues; contribution to the EMA network training in particular on innovative non-clinical methods and application of the 3Rs (replacement, refinement, reduction) principles. Successful candidates are likely to have one or more of the following elements in their background: Experience in the activities described above in regulatory authorities, research & development in industry or in academia; Experience in applying ERA and 3Rs concepts; Familiarity with relevant aspects of regulatory applications, experience in identifying issues and required regulatory actions in relation to ERA, including the step-wise procedure to assess risk to the environment of new active substances; Good understanding of non-clinical drug development; Elements that will be taken into account in determining candidates to be invited for interview: General knowledge of EU institutions and bodies including the Agency and the pharmaceutical legal framework; Excellent organization skills, proactive work approach and good team-player capability. Experience in design, conduct or review of non-clinical studies; Knowledge of in novel in vitro techniques; Essential requirements for admission: University degree in medicine, pharmacy, pharmacology, epidemiology or any other life science; Evidence of development in at least some of the competences mentioned above; A good command of English and a thorough knowledge of another official language of the European Union. EMA/471207/2015 Page 58/79

59 For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 59/79

60 28. Contract Agent (FGIV), Risk Management Specialist, Scientific and Regulatory Management Department, Human Medicines Evaluation Division (E) Key words: Risk Management, Data analysis, Adverse drug reaction reporting, Statistics, Epidemiology, Pharmacoepidemiology. Reporting to one of the Office Heads responsible for the therapeutic area in the Scientific and Regulatory Management Department of the Human Medicines Evaluation Division, the Contract Agent is responsible to provide scientific support in the areas of risk management, post authorisation safety evaluation and measuring the impact of risk minimisation activities. This objective involves a variety of tasks, including providing scientific input on Risk Management Plans (RMP) and aspects during presubmission activities as well as pre- and post-authorisation evaluation procedures, review of Rapporteurs pre- and post-authorisation RMP assessments, scientific and regulatory science contribution to selected PSUR assessments including peer review and review of labelling changes, as well as peer review of Rapporteur s assessments for PASS protocols and results. Successful candidates are likely to have one or more of the following elements in their background: Knowledge of EU pharmacovigilance and risk management guidelines and procedures; Experience of evaluating pharmacovigilance and epidemiology data and studies; Thorough understanding of clinical drug development; Good understanding of the methods and biostatistics applied in clinical trials and epidemiology. Elements that will be taken into account in determining candidates to be invited for interview: Experience in the risk management, pharmacovigilance or pharmacoepidemiology obtained either through previous work at the Agency, at a national competent authority, in academia or in industry; Good understanding of the European regulatory framework in the field of pharmaceuticals; Ability to perform in the spirit of proactive collaboration and team-work cross-functionally. Essential requirements for admission: University degree in medicine, pharmacy, pharmacology, epidemiology or any other life science, with good evidence of development in the competences mentioned above; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stag EMA/471207/2015 Page 60/79

61 29. Contract Agent (FGIV), Scientific and Regulatory Management Department,, EMA Product Lead Human Medicines Evaluation Division (E) Keywords: Infectious diseases, Influenza, HIV, Vaccines, Tropical diseases, Central Nervous System, Ophthalmology, Diabetes, Endocrinology, Cardiovascular diseases, Diabetes, Oncology, Rheumatology, Gastroenterology, Pulmonology, Clinical Immunology, Internal Medicine. Reporting to one of the Office Heads responsible for the therapeutic area in the Scientific and Regulatory Management Department of the Human Medicines Evaluation Division, the Contract Agent is responsible for clinical and regulatory science input for a portfolio of products/disease area from initial marketing authorisation (including pre- submission) and through post-authorisation. This objective involves a variety of tasks, including contribution to the product evaluation with regard to procedures requiring critical clinical or regulatory science input, fostering quality of content through peer review throughout procedures, collecting and condensing key scientific documents to support evaluation activities, and contributing to ensure high-quality product information for an assigned product portfolio, from clinical/nonclinical perspective. Furthermore, oversight of output provided by the product team in relation to product evaluation is required. Successful candidates are likely to have one or more of the following elements in their background: Medical training or other professional experience in at least one of the following: Infectious Diseases, Central Nervous System Diseases, Endocrinology, Cardiovascular Diseases, Oncology, Clinical Immunology, Rheumatology, Gastrointestinal Diseases, Respiratory Diseases, Nephrology, Dermatology; Thorough understanding of clinical drug development; Good understanding of the methods and biostatistics applied in clinical trials. Elements that will be taken into account in determining candidates to be invited for interview: Experience in the scientific evaluation of medicinal products for human use obtained either through previous work at a national competent authority, in academia or in industry; Good understanding of the European regulatory framework in the field of pharmaceuticals; Ability to perform in the spirit of proactive collaboration and team-work cross-functionally; Highly developed communication skills for facilitation of collaboration and building relationships with a variety of stakeholders. Essential requirements for admission: University degree in medicine, pharmacy or any other life science, with good evidence of development in the competences mentioned above; A good command of English and a thorough knowledge of another official language of the European Union. EMA/471207/2015 Page 61/79

62 For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 62/79

63 30. Contract Agent (FGIV), Quality of Medicines for Chemical and Biological Medicinal Products, Human Medicines Evaluation Division (E) Keywords: Pharmacy, Quality (also: Chemical, Synthesis, Manufacturing, Generic, Biological, Vaccine, Blood Product, Advanced therapies). A Contract Agent working within the Quality Office will report to the Head of Office, who is responsible for quality aspects of chemical or biological medicinal products. The Quality Office is part of the Specialised Scientific Disciplines Department in the Human Medicines Evaluation Division. The Quality Office provides coordination and oversight of quality aspects for procedures for Marketing Authorisation Applications (MAA), scientific advice requests and a range of other activities across the lifecycle of a medicinal product. The Office deals with chemical and biological medicines and is composed of specialists who have acquired both regulatory and technical competence in topics ranging from solid dosage forms through to advanced therapy medicinal products. This position will suit a scientist who has developed a good understanding of pharmaceuticals and the application of chemistry and other life sciences to the manufacture and controls of pharmaceutical products. In particular, the successful candidate is expected to carry out the following tasks: Review of assessment reports from a quality perspective to ensure scientific consistency and robustness and the provision of scientific input into complex aspects arising during evaluation procedures (MAA, scientific advice, quality defects, orphan similarity, PIP requests, etc.); Interact with stakeholders (e.g. EU network including EDQM, pharmaceutical companies, international regulators, etc.). This work will involve interactions with: Rapporteurs and Co-rapporteurs - scientific, technical and administrative support for the assessment of products; Main Scientific Committees; Working Parties - scientific or regulatory projects involving the Agency s committees, groups of experts /Working Parties; External stakeholders and pharmaceutical industry; Co-ordinating the activities essential to the establishment of objective scientific opinions on medicinal products for human use; Other Units and Sectors on activities related to Chemical and Biological Medicinal Products. In addition to this core activity, there are a number of associated supportive tasks / projects. EMA/471207/2015 Page 63/79

64 Elements that will be taken into account in determining candidates to be invited for interview: Scientific training in pharmacy or other life sciences along with experience in project management of the type of activities described above; General knowledge in the field of development pharmaceutics, formulations and manufacture and control of medicinal products; Specific skills are expected in some of the following technical elements: synthetic chemistry, dosage form design, drug delivery including relevant devices, dissolution and bioavailability, age appropriate formulations, validation and quality control, biotechnology, vaccines, plasma derived products, viral safety, advanced therapies (cell, gene, tissue engineered products), or other quality-relevant areas; General knowledge of Community institutions including the Agency and the pharmaceutical legal framework is expected. Essential requirements for admission: A university degree relevant to the field of pharmacy or other relevant life science with good evidence of development in the competences mentioned above; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 64/79

65 31. Contract Agent (FGIV), Labelling Specialist, Scientific and Regulatory Management Department, Human Medicines Evaluation Division (E) Keywords: Product information, Labelling review, Medication errors, Name review, Packaging review, Quality Review of Documents, User Testing. Reporting to the Head of the Labelling Review & Standards Office in the Scientific and Regulatory Management Department of the Human Medicines Evaluation Division, the Contract Agent is responsible to ensure compliance of the product information with current standards, consistency with SmPC guideline and early identification of potential for medication errors in relation to packaging and naming issues. General objectives: Responsible for ensuring the quality and consistency of product information throughout the review process; Maintain the product information templates as well as the standards for mock-ups and specimens; Review of mock-ups and specimens with the aim to ensure correct identification and safe use of the medicinal product; Organise and coordinate the name review process with the aim to avoid confusion and address public health concerns in particular with regard to safety; Address risks of medication errors linked to labeling aspects; Provide support to EMA Committees and Working Parties with regard to guidelines, core SmPCs (Summary of Product Characteristics) and templates impacting on labelling; Develop and maintain guidance related to labelling; Work within a multidisciplinary team including EPL (EMA Product Lead), RMS (Risk Management Specialist) and procedure manager/assistant to support development of a complete and accurate Product Information; Responsible for the operational aspects of the Quality Review of Documents (QRD) working party and Name Review Group (NRG) activities, including agendas, ToDs (Table of Decisions), links with relevant committees etc.; Responsible for providing internal/external training on labelling requirements; Responsible for defining business requirements for the development of IT systems that support labelling review; Reply to internal and external queries in relation to LRS activities; Monitoring and analysing of results of consultation with target patient groups (User Testing). Successful candidates are likely to have one or more of the following elements in their background: Professional experience in the management of product labelling; EMA/471207/2015 Page 65/79

66 Knowledge in the potential for medication errors in relation to packaging and naming issues; Understanding of clinical drug development. Elements that will be taken into account in determining candidates to be invited for interview: Experience in the evaluation of medicinal products for human use, from either a scientific or regulatory perspective, obtained either through previous work at a national competent authority or in industry; Good understanding of the European regulatory framework in the field of pharmaceuticals; Excellent organisation skills; Ability to perform in the spirit of proactive collaboration and team-work cross-functionally; Highly developed communication skills for facilitation of collaboration and building relationships with a variety of stakeholders. Essential requirements for this post are: University degree in medicine, pharmacy or any other life science, with good evidence of development in the competences mentioned above; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 66/79

67 32. Contract Agent (FGIV), Clinical Pharmacology, for Human Medicines Development and Evaluation Division (E) Keywords: Clinical Pharmacology (also: pharmacokinetics, pharmacodynamics, pharmacogenomics, biomarkers, bioequivalence, dosefinding, extrapolation). A Contract Agent working within the Clinical Pharmacology and Non-clinical Support Office will report to the Head of Office, who is responsible for the clinical pharmacology aspects of chemical or biological medicinal products. The Office is part of the Specialised Scientific Disciplines Department in the Human Medicines Evaluation Division. The Clinical Pharmacology and Non-clinical Support Office provides coordination and risk-based oversight of clinical pharmacology aspects for procedures for Marketing Authorisation Applications (MAA), scientific advice requests and a range of other activities across the lifecycle of a medicinal product. The Office is composed of specialists who have acquired both regulatory and technical competence in topics ranging from Pharmacokinetics through biomarkers and innovative designs in early clinical development of medicinal products. In particular, the successful candidate is expected to carry out the following tasks: Review of assessment reports from a clinical pharmacology perspective to ensure scientific consistency and robustness and the provision of scientific input into specific aspects arising during evaluation procedures (MAA, scientific advice, CMD(h) bioequivalence, orphan similarity, PIP requests, etc.); Interact with stakeholders (e.g. EU networks, pharmaceutical companies, international regulators, etc.); Good understanding of the role of clinical pharmacology in to the development and evaluation of medicinal products. This work will involve interactions with: Rapporteurs and Co-rapporteurs - scientific, technical and administrative support for the assessment of products; Main Scientific Committees; Working Parties - scientific or regulatory projects involving the Agency s committees, groups of experts /Working Parties; External stakeholders and pharmaceutical industry; Co-ordinating the activities essential to the establishment of objective scientific opinions on medicinal products for human use; Other Divisions and Departments on activities related to Medicinal Products. In addition to this core activity, there are a number of associated supportive tasks / projects. EMA/471207/2015 Page 67/79

68 Elements that will be taken into account in determining candidates to be invited for interview: Scientific training in medicine or other life sciences; General knowledge in the field of pharmacokinetics, pharmacodynamics and dose response studies; Specific skills are expected in some of the following technical elements: pharmacokinetics, pharmacodynamics, pharmacogenomics, bioequivalence, food and drug-drug interactions, extrapolation, and biomarkers; General knowledge of Community institutions including the Agency and the pharmaceutical legal framework is expected. Essential requirements for admission: A university degree in medicine or other relevant life science; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 68/79

69 33. Contract Agent (FGIV), Veterinary Medicines Sector, Veterinary Medicines and Product Data Management Unit (V) Keywords: Authorisation of veterinary medicinal products, Establishment of Maximum Residue Limits, Scientific, technical and administrative support. The Contract Agent would be responsible in particular for managing procedures concerning the authorisation of veterinary medicines. This may cover pharmaceutical or immunological (including biological) veterinary medicinal products and cover all stages of the product lifecycle from initial application, through assessment of the safety of residues for the purpose of establishing Maximum Residue Limits in the case of substances for food producing species, through risk assessment for the purpose of marketing authorisation to maintenance and pharmacovigilance, liaising, as appropriate, with rapporteurs/experts and Working Parties/expert groups and the Committee for Medicinal Products for Veterinary Use (CVMP). Successful candidates are likely to have one or more of the following elements in their background: Knowledge of the European pharmaceutical legislation and the procedures for authorisation of veterinary medicinal products and familiarity with, or previous experience of, the establishment of MRLs in the EU; Knowledge in pharmacology, toxicology, immunology or a related sciences; Understanding of the principles and practice of risk assessment for regulatory purposes. Elements that will be taken into account in determining candidates to be invited for interview: Previous experience of working in fields relevant to the authorisation of veterinary medicines; Good project management skills; Good written and oral communication skills; Good organisational skills; Good interpersonal skills and the ability to work closely within a small team of professionals; Experience of working in a multicultural environment. Essential requirements for this post: A university degree in veterinary medicine, human medicine, pharmacy or other life sciences as appropriate with good evidence of competences relating to the field covered by the above description of duties; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement candidates will be required to provide proof at the inter69 EMA/471207/2015 Page 69/79

70 34. Contract Agent (FGIV), Compliance and Inspection Department (P) Keywords: Medicine, Pharmacy, Manufacturing, Quality, Inspector, Inspection, Audit, Compliance, Scientific committees, Clinical, Monitor, CRA, Non-clinical, Pharmacovigilance, Parallel distribution, Statistics, Database, Testing. Reporting to one of the three Section Heads for Clinical and non-clinical compliance, Manufacturing and Quality Compliance and Certificates or Parallel Distribution, the Contract Agent would be responsible in particular for scientific and organisational support for GCP, GLP, GMP and Pharmacovigilance inspections and inspections in the context of the Plasma Master File and Vaccines Antigen Master File, organisation of the issuing of Certificates of Medicinal Products and Notification of Parallel distribution, and sampling and testing of medicinal products. Successful candidates are likely to have more than one of the following elements in their background: Scientific training in the healthcare field (medicine, pharmacy) or other relevant life science with particular knowledge of advanced therapies; Work experience involving European pharmaceutical legislation, guidelines and procedures relevant to the activities described; Work experience in providing support to scientific committees. Elements that will be taken into account in determining candidates to be invited for interview: Practical work related to manufacturing and/or clinical research or relevant work in the pharmaceutical sector either within a regulatory authority or industry environment; Experience in database requirements and management. Essential requirements for this post: A university degree in a relevant health science with good evidence of development of the competences mentioned above; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 70/79

71 35. Contract Agent (FGIV), Procedure Manager, Evaluation Procedures A-F services in Procedure Management department, Procedure Management and Business Support Division (C) Keywords: marketing authorisation, referrals, regulatory, risk, safety. With responsibility under one of the Service Heads in the Procedure Management department, the Contract Agent will manage initial marketing authorisation, post authorisation, safety, maintenance and referral procedures in accordance with legal and regulatory requirements. Responsible for estimating in close collaboration with the EPL (EMA Product Lead) procedural complexity and for handling the procedure accordingly, with the aim to utilise the internal and external network resources in a risk-proportionate manner. Also responsible for using the available escalation routes and requesting input from the EPL and/or the relevant scientific discipline specialist, as needed. Main contact point on procedural aspects for EC (European Commission)/experts and applicants. Also responsible to drive further process simplification and efficiency. In particular, the successful candidate is expected to carry out the following tasks: Ensuring compliance with procedural regulatory requirements e.g. correct legal basis, correct procedure type; Adherence to regulatory timelines; Correctness of Committee inputs/outputs relating to procedures e.g. agendas, TODs (Table of Decisions), documents; Defining the procedural handling for each procedure according to agreed risk-based criteria; Escalating and requesting input from the EPL or specialised disciplines specialists, when needed according to agreed pre-defined criteria; Ensuring that the scientific aspects of the assessment are captured in the procedure e.g. include similarity assessment, paediatric requirements, new active substance status; Ensuring soundness of the evaluation outcome for procedures where the business process does not require core product team involvement; Tracking parallel procedures affecting the same product and keeping the EPL informed to ensure consistency of outcomes; Responsible for communicating within the core product team about the procedural outcomes; Principal contact for applicants and EC for procedural aspects of the application; Ensuring that up-to-date templates are available and used for the procedure; Accountable for providing guidance to Rapporteurs, applicants and the EPL on the procedural handling of the application; Responsible together with RA (Regulatory Affairs) for developing and maintaining up-to-date regulatory procedural guidance; EMA/471207/2015 Page 71/79

72 Ensure the correct fee is determined for each procedure; Responsible for providing internal/external training on regulatory procedural requirements; Support the continuous improvement of the Procedure Management Team through identification and implementation of process improvements/simplifications. This involves: Defining and setting targets for key process performance indicators to ensure process efficiency ; Monitoring and regular review of process performance metrics; Identification of improvement opportunities; Implementation of improvement actions; Documenting procedures in the context of IQM (Integrated Quality Management); Accountable for the correctness of procedure related database entries and records management policies; Responsible for defining business requirements for the development of IT systems that support procedures ; Responsible for escalation of organisational and procedural issues to Head of Service as needed. Successful candidates are likely to have the following qualifications and background experience in the following areas: General scientific understanding of the pharmaceutical and safety/efficacy aspects of the submission; Strong knowledge of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures underlying the pharmaceutical marketing authorisation activities; Strong project management, writing, interpersonal, communication, problem solving, negotiation and organisational skills; Ability to work with cross-functional teams. Essential requirements for admission: A university degree in Pharmacy/Medicines or other life sciences; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 72/79

73 36. Contract Agent (FGIV), Data Scientist, Data Collection and Management service, Procedure Management and Business Support Division (C) Keywords: Data analysis, data management, data validation, SAS. With responsibility under the Service Head for Data Collection and Management, the Contract Agent will contribute to use the data/information assets available at the agency and their interrelationships to extract knowledge from them and derive recommendations/suggestions to support fact-based business/scientific decision making. General objectives: Validating as required the EudraVigilance and Art57 data; Coordinating and validating the work of the external EV Data Management contractor; Contribute to the definition of requirements and specifications for integrating data Quality Control (QC) into the data lifecycle; Liaising with stakeholders to capture their needs in order to publish dashboards and to provide them with access to the aggregated data to efficiently meet their goals and objectives; Performing statistical analysis, data mining, data integration, data retrieval, scenario forecasting, producing reports and visualising the results of the analyses in the most appropriate way; Provide SAS programming and scientific support to the Best Evidence (IMS) data analysis. Successful candidates are likely to have the following qualifications and background experience in the following areas: Knowledge of the pharmacovigilance legal framework; Experience in working with Pharmacovigilance and Medicinal Product data; Experience in the use of MS Excel and SAS; Ability to network and interact effectively with colleagues and work as part of a team. Essential requirements for admission: A university degree in Pharmacy/Medicines or other life sciences; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 73/79

74 37. Contract Agent, Access to document Manager, Access to Document service, Procedure Management and Business Support Division (C) Keywords: access to document, transparency, redaction. With responsibility under the Service Head for Access do Document (ATD), the Contract Agent will manage the most complicated requests to access documents: process and documents. The job holder will be responsible for clarifying requests, exchanging with all stakeholders involved, estimating workload, ensuring respect of legal timelines and preparation of documents in line with EMA redaction principles. Also responsible for escalating the request to access documents to the ATD Management Team for advice prior to a decision being taken by the EMA, and accountable for the process management of requests to access documents as per their assigned ATD portfolio. General objectives: Principal contact for requester and any third party involved in the ATD request; Ensuring that a request to access documents is clear and meets the regulatory criteria; Responsible for providing guidance to all stakeholders; Adherence to legal timelines; Estimating complexity, workload and release timelines for their assigned ATD requests; Assessing the need to bring the ATD request to the ATD meeting (ATDMT) for discussion or information prior to the EMA taking any decision; Ensuring that the correct documents have been identified to satisfy the need of the requester; Ensuring that all steps of the process are followed; Ensuring that the correct templates are used for the process and flagging any updates required; Ensuring that the documents have been correctly redacted according to the EMA redaction principles; Responsible for identifying legal issues and escalating them to the legal officer in charge of the ATD request; Responsible for managing any assistant who may have to help with complex ATD requests, defining tasks, timelines, providing guidance; Accountable for the accuracy of entries in the workflow tool and in the ATD tracking table; Accountable for the correct filing in DREAM; Responsible for preparing the redaction guidelines assigned to them. Successful candidates are likely to have the following qualifications and background experience in the following areas: Scientific understanding of pharmaceutical and safety/efficacy aspects of the submission; EMA/471207/2015 Page 74/79

75 Strong knowledge of regulatory aspects of procedures. Essential requirements for admission: A university degree in Pharmacy/Medicines or other life sciences; A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 75/79

76 38. Contract Agent (FGIV), Committees Secretariat, Scientific Committee Support Department, Procedure Management & Committee Support Division (C) Keywords: Scientific Committee support, Community legislation, Centralised procedure, Mutual recognition procedure, Referral procedure. With responsibility under the Service Head for Scientific Committee Support service, the Contract Agent will provide, as a member of a centralised Scientific Committee Co-ordination group, efficient and high quality organisational, scientific, technical/regulatory and procedural support to (one or more of) the EMA Scientific Committees as required: Committee for Medicinal Products for Human Use (CHMP), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO), the Committee for Herbal Medicinal Products (HMPC), the Committee for Advanced Therapies (CAT) and their associated Working Parties, as well as to the Co-ordination Group for the Mutual Recognition Procedure and Decentralised Procedure - human (CMDh). General objectives: all aspects of plenary CAT, CHMP, CMDh, COMP, HMPC and PRAC meeting operations; co-ordination of cross committee interactions with other Scientific Committees and their working parties; management and monitoring of Committee Workplans; and coordination of adequate scientific support from responsible business areas. Successful candidates are likely to have the following qualifications and background experience in the following areas: Specific professional experience in the field of European regulatory affairs related to the activities identified above, irrespective whether acquired through working in the pharmaceutical industry, national, European or worldwide regulatory authority, academia, or equivalent institutions; Operational experience of European evaluation procedures e.g. Centrallised procedure, Mutual Recognition Procedure, Decentralised procedure, Community referral procedure; In-depth understanding of Community Legislation in the field of pharmaceuticals; Experience of interaction with industry/regulatory authorities. Essential requirements for admission: A university degree in pharmacy, medicine or life sciences; A good command of English and a thorough knowledge of another language of the Communities to the extent necessary for the performance of duties. For the first essential requirement it will be necessary to provide proof at the interview stage EMA/471207/2015 Page 76/79

77 39. Contract Agent (FGIV), Legal Department Keywords: Legal, legal advice, pharmaceutical law, Staff Regulations, access to documents, EU procurement law, anti-fraud. The Legal Department has overall responsibility for handling all legal issues arising within the EMA. It provides advice and support to the Executive Director, Management Board, all Divisions/Departments/Services/Offices, and to third parties, where appropriate, in the light of EMA business and policy objectives. Reporting either to the Head of Legal Department, Deputy Head of Legal Department or one of the Office Heads, the Contract Agent would be responsible for carrying out one or more of the following tasks: General objectives: Provision of legal assistance on legal matters arising out of regulatory issues for which the Agency is responsible under Regulation (EC) No. 726/2004, (EC) No. 141/2000, (EC) No. 1901/2006, (EC) No. 658/2007, (EC) No.1394/2007, (EC) No. 470/2009, Directive 2001/82/EC, Directive 2001/83/EC and other relevant legal texts; Provision of legal assistance with particular attention to facilitate the Agency and its scientific committees operations pertaining to the authorisation and supervision of medicinal products for human and veterinary use; Provision of legal assistance on matters arising in connection with the Staff Regulations, contracts and procurements, transparency and access to documents, anti-fraud related activities, data protection and other general policy areas. Elements that will be taken into account in determining candidates to be invited for interview: Experience in dealing with the EU legislation in the pharmaceutical field; Experience in dealing with any or all of the following matters: EU Staff Regulations, EU contracts and procurements, EU access to documents and information, EU data protection, matters concerning the European Ombudsman, matters concerning anti-fraud related activities/strategies; Experience in working in a multicultural environment. Essential requirements for this post: A university degree in law that must have been obtained by the closing date for applications; A good command of English and thorough knowledge of another official language of the European Union. EMA/471207/2015 Page 77/79

78 40. Contract Agent (FGIV), Communications Team, Office of the Executive Director Keywords: Press office, Media, Drafting, Editing, Journalism, Public Relations. The communications team is part of the Office of the Executive Director. Working closely with the Executive Director, the department provides secretariat, organisational and policy support to the Agency s management team, has a key role in the Agency s strategic business planning and has responsibility for the Agency s communication with external and internal audiences. The communications team has responsibility for the Agency s communications activities with its internal and external audiences. Work focuses on responding to media enquiries, managing and developing content for the Agency s external and internal websites, producing external and internal information documents and assisting in the ongoing exercise to develop and implement a communications strategy for the Agency. Reporting to the Head of Sector, and working closely with the existing external communications manager as part of the press office team, the Contract Agent would be responsible for the following tasks: General objectives: Drafting, editing and revising press releases and other information for media and other external and internal audiences and managing the internal approval process; Handling and responding to media enquiries; Planning, coordinating and implementing external communication strategies and projects; Contributing news and topical items for the Agency s website; Managing and coordinating media activities such as briefings, interviews, press conferences and other media events; Monitoring and evaluating the Agency s communications activities and making recommendations for improvements. Successful candidates are likely to have proven work experience in the following areas: Media/public relations or journalism, preferably in a public-health or scientific environment, relevant to the description of duties above; Used to be working in an environment where English is the main written and spoken language (the source language of all the Agency s scientific and communication documents is English); Extremely strong written skills with the ability to summarise and present ideas and themes coherently and concisely. EMA/471207/2015 Page 78/79

79 Essential requirements for this post: A university degree in journalism, communications, European or international relations, public health administration or other relevant subject. A good command of English and a thorough knowledge of another official language of the European Union. For the first essential requirement it will be necessary to provide proof at the interview stage. EMA/471207/2015 Page 79/79