Careers in Medical and Scientific Writing



Similar documents
Medical Writing in Focus A Med Comms Agency Perspective. Mike Thompson Scientific Director, Complete Medical Group

The agency perspective

The agency perspective: What we do and how we do it

Medical Science Liaison (MSL): Understanding, Engaging and Interacting. Gill Logan Regional Medical Affairs Manager Takeda UK

Master of Science in Medical Writing Curriculum*

Regulatory Writing Clinical Project Management Strategic Communications

Fulfil your potential with a career in medical communications

Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / Pharmaceutical Industry

Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA

Background: Pathways for the Master s Degree (Thesis and Non Thesis)

The Role of Regional Medical Advisor (RMA)-Field Medical. Dr. Aju Abraham Varghese Pfizer India. Feb 22 nd 2014

Performance Profile. Clinical Study Physician. 1

My life as a medical writer. Karen Wilson Smith PhD

Medical Writing. What is medical writing? What qualifications and skills do I need?

Engaging Clinical Trial Sites:

PROJECT MANAGEMENT AS A CAREER PATH FOR PHDS: PERSPECTIVE FROM BIOTECH AND NONPROFIT SECTORS

CERTIFICATE IN BASIC PHARMACEUTICAL DEVELOPMENT Focusing on the Business of Pharmaceuticals

A clinical research organization

Patience In Patient Recruitment

ectd Digital Handbook Table of Contents

A non-traditional approach to promoting innovation and entrepreneurship

GenScript USA Incorporation:

CLINICAL RESEARCH GENERIC TASK DESCRIPTIONS

Business Conduct Standards for Interactions with Healthcare Professionals. Pocket Guide for U.S. Sales Professionals. Do The Right Thing

Clinical Communications Programs with Healthcare Professionals and Patients

Voluntary Genomic Data Submissions at the U.S. FDA

INFORMATION FOR GRADUATE STUDENTS IN BIOCHEMISTRY. Department of Chemistry and Biochemistry Utah State University, Logan, Utah

NDA /S-008 SUPPLEMENT APPROVAL

Safety Risk Management Company Perspective

Sales. Designation: Associate Vice President. Roles & Responsibilities. Establish qualification strategy

Cynthia L. Saver, RN, MS CLS Development, Inc. Columbia, MD. (410)

Strategic Consulting Services

Introduction to Compliance with FDA Labeling and Advertising Requirements

PharmD Postdoctoral Fellowship Program

Course Certificate In. Pharmaceuticals and Medical Research: Clinical Research Monitoring & Coordination

Association-Related Programs

COLLEGE OF PHARMACY Graduate Assessment Plan (Master s program)

A Primer: Solving the Unique Problems of Orphan Drug Communications Programs

CTC Technology Readiness Levels

Mood Disorders in PD: What s New?

AMERICAN PSYCHIATRIC NURSES ASSOCIATION. Collaborating in an Evolving Health Care System: Opportunities to Advance Psychiatric-Mental Health Nursing

Associate Group Director, Regulatory Intelligence & Policy

) UC 6:30 8:20 PM

Bachelor of Science in Pharmaceutical Sciences (BSPS) Program Overview and Internship Requirements

RAPS ONLINE UNIVERSITY

Interactive Programs. genrmedia.com. 845 Third Avenue, 6th Floor New York, New York

The Clinical Trials Process an educated patient s guide

Regulatory Affairs Graduate & Postgraduate Program. Novartis Pharma AG Novartis Animal Health AG

Writing, Rhetoric and Technical Communication

Goals & Objectives. Drug Development & the FDA Pharmacy 309. Outline. An History of Disasters. Be able to describe

Approximate cost of a single protocol amendment: $450,000

Food and Drug Administration

Animation Overview of the Industry Arts, AV, Technology, and Communication. Lesson Plan

DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health

Mina Varsani. Been there, done it, got the T- shirt. Life in Med Comms

Job Profile Clinical Research Associate III (CRA)

Comparison of Clinical Trials Registry Legislation in the Senate and House Prepared by Tannaz Rasouli, AAMC Office of Governmental Relations

The Product Review Life Cycle A Brief Overview

Nutraceutical Medical Research, LLC. By: Latesha Richards, Marketing Coordinator

Is a Career in the. Pharmaceutical. Check out our online Student Center to find out more:

Career Opportunities in Physiology Committee

THE BIOTECH & PHARMACEUTICAL INDUSTRY

Why Are Drugs So Expensive? Learning About the Drug Development Process

A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market

How To Get An Mba

Pharmaceutical & Chemical Sciences Graduate Program

Singapore Clinical Trials Register. Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY

GRADUATE PRACTICUM IN PUBLIC HEALTH PH

Drug Development Process

Challenges in the Regulation of Pediatric Clinical Trials

Emergence of Compassionate Use programmes

European Federation of Pharmaceutical Industries and Associations (EFPIA) HCP/HCO Disclosure Transparency Requirements Methodology Note for Shire

Guidance for Industry

2009 Foley & Lardner LLP Attorney Advertising Prior results do not guarantee a similar outcome Models used are not clients but may be representative

Roles & Responsibilities of the Sponsor

4.1 Objectives of Clinical Trial Assessment

University of Cambridge: Programme Specifications MASTER OF PHILOSOPHY IN NUCLEAR ENERGY

Post-Doctoral Pharmaceutical Industry Fellowships. Two-Year Clinical Development Program Two-Year Clinical Safety Program

School of Pharmacy TEMPLE UNIVERSITY

University of Cambridge: Programme Specifications MASTER OF PHILOSOPHY IN ENGINEERING FOR SUSTAINABLE DEVELOPMENT: PROGRAMME SPECIFICATION

Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009

Guidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions

Overview of Drug Development: the Regulatory Process

Licensure. Registered Pharmacist New York - License number Certifications. WMD Cardiology ACLS / PALS Pharmacist Immunizer

What to expect of life in a MedComms Agency. Is Agency life for you?

February 2006 Procedural

FDA Tobacco Regulatory Science Fellowship

GOG Foundation/Partners Program Overview 2015

CERTIFICATE IN CLINICAL TRIAL MANAGEMENT

Abt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services

Medical Illustrator. Medical illustrators use their knowledge of art and science to create illustrations for the health and medical fields.

Role of the Investigational Drug Services (IDS) in the Management of Investigational Drugs

Perspectives on Patient Recruitment

Thomas Hinchliffe, Pharm.D. CDR, U.S. Public Health Service Special Assistant to the Director Office of Generic Drugs Food and Drug Administration

ALIA Information Online Conference

FACULTY OF PHARMACEUTICAL MEDICINE

Richard M. Fairbanks School of Public Health Master of Public Health Program Final Concentration Project Proposal Form

St. John s University. College of Pharmacy and Allied Health Professions. Annual Objectives Revised 7/22/10

WHO WE ARE. Our Services

Transcription:

Careers in Medical and Scientific Writing Laura McCormick, PhD Vice President Associate Practice Leader Tamara Fink, PhD Associate Scientific Director ProEd Communications, Inc Beachwood, Ohio

Agenda Introduction to ProEd Introduction to medical and scientific writing Career options Work product examples Qualifications, experience, and training Resources

ProEd: Who We Are Founded in 1991 Fully integrated health science communications company Headquartered in Beachwood, Ohio ~80 employees with diverse perspectives Domestic and global execution

The Healthcare Consultancy Group Omnicom Group Diversified Agency Services (DAS) > 160+ marketing services and specialty communication companies A&P PR Branding DTC/DTP Medical education

Why Consider A Career In Medical Writing? Work is engaging Diverse exposure to therapeutic areas Cutting edge drug development Lucrative and in high demand See the world

Prague, Czech Republic

Career Options Scientific communications / medical education Pharmaceutical industry General science or medical publications industry Advertising Freelance writing

Employers Research or Education Healthcare organization Other Contract research organization 5% 7% 7% 14% 10% Univ or med school Pharmaceutical company 34% Communication / advertising agency 12% 8% Journal or publisher 3% Association or professional society

Medical Writing Opportunities Within the Pharmaceutical Industry Scientific communications Manage publications plans Develop manuscripts, abstracts, posters Medical education Medical promotion Regulatory Develop clinical study reports (CSR) Write new drug application (NDA) documents Support preparations for FDA meetings such as advisory committee meetings (ACM)

Portugal Lisbon Porto

What is medical writing all about?

Publications Manuscripts Congress activities Abstracts Posters Oral presentations Booth materials

Supportive Publications Services Strategic literature analyses Congress intelligence Ad hoc scientific analyses Interactive CD-ROM bibliography Supplements White papers

Booth Collaterals

Illustration

Medical Education Corporate-sponsored symposia at medical congresses Speaker training Speaker bureau Slide libraries Website content Key opinion leader portals Monographs

Education Materials

Slide Libraries

Web Portals

Pharmaceutical Company Training and Information Services Sales representative training manuals Medical science liasion (MSL) materials Training Physician education Question and answer documents Reference libraries

Training Materials

Oncology Learning System

Regulatory Clinical trial protocols Investigators brochure and updates Regulatory documents Clinical Study Reports (Phase I-IV) Integrate safety summaries Patient narratives Policy documents Submissions (investigational new drug application) IND and NDA annual reports, amendments, supplements Advisory committee preparation FDA advisor briefing book

Promotion Newsletters Patient education materials Public relations materials Advertising copy for pharmaceuticals and other products Internet content CDs Magazine articles - popular press Detail aids Launch materials

Who Does What In The Agency World? Promotion Legal / Regulatory Advertising Agency Full Service Medical Communications Clinical Research Organization Advertising Trade press Sales aids Training materials Booth materials Drug development strategy Publications Congress materials Advisory boards Regulatory consulting Health economics research and pubs Clinical study reports IND NDA BLA

Medical Writing Services: ProEd Scientific Communications Advisory boards Scientific content development Scientific animations Interactive education solutions Meeting & conference programming Competitive intelligence Disease backgrounders Scientific research support Regulatory Communications Health authority Meetings FDA advisory committee meetings EMEA Submission management Risk management Labeling negotiation strategy Medical Strategy and Promotion Strategy workshops Market shaping & preparation strategy HCP promotional education Sales force education Branding through visual nomenclature & animation Patient education & community marketing Medical expert relationships High science

Select Client List

Barcelona, Spain Sacrada de familia Gaudi Park Güell

How do I get there from here?

Qualifications Attention to detail - thorough and accurate Good communication skills (written and verbal) Ability to write well and tailor information to specific audiences Clear, concise Logical story flow Ability to work with team members of diverse educational backgrounds Ability to work independently (often remotely) Deadline oriented Good organization and management skills

Education and Training Education level parallels job requirements BS or MS PhD Often requires 1-2 years postdoctoral training PharmD MD Excellent software skills May require testing or additional training

Training and More Information Read medical and pharmaceutical journals Subscribe to online newsletters (e.g. National Center for Education in Maternal and Child Health) Study basic statistics Obtain and be familiar with style guides and medical dictionaries (eg AMA) Familiarize yourself with FDA guidelines Gain software skills (MS Word, PowerPoint, Excel)

Training and More Information Complete a course in pharmacology Enroll in AMWA s continuing education certification program Medical writing program through college or university Pharmaceutical Education & Resources Institute Pharmaceutical industry training courses Focus on drug development and marketing

Choosing Between Freelance Writing and Industry (Pharma or Agency) Decision rests on Experience Financial and lifestyle needs Tolerance for risk Preference for team environment vs solo Personal motivation and discipline Industry trends and job market

Additional Resources Bonk RJ. Medical Writing for Pharmaceutical Research. In: Medical Writing in Drug Development. A Practical Guide for Pharmaceutical Research. New York, NY: The Pharmaceuticals Product Press; 1998:3-36. American Medical Writer s Association http://www.amwa.org Links training, ethical publications guidance, medical writing resources...

Additional Resources Drug Information Association http://www.diahome.org/diahome Pharmaceutical Education & Resources Institute http://www.peri.org/become_faculty.cfm National Association of Science Writers http://www.nasw.org Pharmaceutical regulatory affairs training http://www.iir-events.com/iirconf/pti/eventview.aspx?eventid=1621

Additional Resources Center for Professional Innovation and Education (Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries ) http://www.cfpie.com A Marketing Primer for Freelance Medical Writers, Lori De Milto, AMWA Journal, Vol. 14, No. 2, Spring 1999. AMA Manual of Style: A Guide for Authors and Editors. JAMA & Archives Journals, Mar 15, 2007.

Contact information: Terri Bednar, HR Generalist Phone: 216 378-8854 Phone: 216 595-7919 e-mail: terri.bednar@proedcom.com