Career Paths for Medical Writing

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Career Paths for Medical Writing ASPET Diversity Mentoring Breakfast April 27, 2014 Victoria A. Love, PhD www.linkedin.com/in/valovephd/

Today s Agenda Present a brief introduction Define medical communications and medical writing Describe the scope of work encompassed by the field Provide information pertaining to how to establish a career in the field Discuss my professional journey Offer information about resources Give an overview of tests developed by medical communications employers Answer any questions

Current Professional Bio Scientific Operations; Section Manager of Documentation and Archiving; Drug Safety Evaluation (DSE)- Allergan, Irvine, CA Non-clinical sections for global drug applications Non-clinical study related protocols & reports Toxicology, Pharmacokinetics, Bioanalytical and Immunology reports (> 600 annually) Support information platforms that support transfer and storage of electronic documents used by DSE >20 submissions scheduled for 2014

Current Professional Bio Scientific Operations; Section Manager of Documentation and Archiving; Drug Safety Evaluation (DSE)- Allergan, Irvine, CA Facilitates archival of all study and submission related documents Manages training curricula for > 200 employees Oversee the regulation of Standard Operating Procedures (SOPs) and controlled form documents for DSE Supports electronic platforms that support transfer and storage of documents used by DSE Coordinates inspections and audits

Life After Academia Career Options for Scientists Patent Law Science Research Analyst postdoc Scientific Consulting Medical Science Liaison Other Alternative Careers in Science: Leaving the Ivory Tower by Cynthia Robins-Roth

What Do Medical Writers Do All Day? Medical Communications Encompasses the development and production of materials that deal specifically with medicine or healthcare Write, edit, or develop materials about medicine or healthcare Medical Writing is the activity of writing scientific documentation by someone who is a specialized writer (a medical writer) and is generally not one of the scientists or doctors whose research it was

Medical Communications: General Categories Materials prepared by medical communicators, collaborating with others or working independently, include the following: Patient education brochures, news articles, Web content, and books for the general public Journal articles and continuing education monographs for health care professionals Regulatory documents for government agencies Grant proposals for research scientists and institutions Sales training and marketing materials for the pharmaceutical industry

Medical Writing: Specific Examples Journal articles Original research Review articles Editorials, case reports, etc. Abstracts Publication in journals Submission to medical meetings Posters Presentation at medical meetings

Medical Writing: Specific Examples Slide presentations Original research Symposia Roundtables Advisory boards Medical education materials Monographs Training materials for physicians, other medical professional & laypeople elearning content Prescribing information

Medical Writing: Specific Examples Regulatory documents Clinical Trial Reports (CTR) New Drug Applications (NDA) Investigational New Drug Application (IND) Marketing materials Advertisements Public relations materials Internet documents Patient education

Required Skills for Medical Writing Attention to detail Excellent writing skills Interpersonal skills Organizational skills Scientific skills Ability to work quickly and multi-task

Characteristics of Good Medical Writing Scientific accuracy Sufficient references and documentation Clear and succint writing Ethical standards and practices

Who Are the Medical Writers? Education by Degree Science English Journalism Pharmacy Medicine Communicat ion Ot her 0 5 10 15 20 25 30 35 40 Gray and Hamilton. AMWAJ, 2004. Medical Writers (%)

Who Are the Medical Writers? Level of Education 2% 30% 33% Associate's Degree or Below Bachelor's Master's Advanced 35%

Primary Employers of Medical Writers Pharmaceutical Agency University Clinical Research Publishing Health Care Research or Education Professional Society Other 0 5 10 15 20 25 30 35 40 Gray and Hamilton. AMWAJ, 2004. Writers %

Freelance Medical Writers 1/3 of Medical writers Work at home Set your own schedule Income based upon ability to get work Discipline Experience Ability to market yourself

Medical Writer Salaries Commensurate with experience and education $38,000-100,000+ Mean income of full-time employees approximately $80,000 Pharmaceutical and communication companies pay best Interesting 6-figure job as seen on CNNMoney.com Gray and Hamilton. AMWAJ, 2004.

Resources American Medical Writers Association (AMWA) http://www.amwa.org/toolkit_new_med_writers#getting Started American Medical Association Manual of Style International Committee of Medical Journal Editors (ICMJE) How to Become a Competent Medical Writer Perspect Clin Res. 2010 Jan-Mar; 1(1): 33 37

Getting Started Practice writing frequently Pay special attention to grammar and style www.grammarly.com (for quick feedback) Improve writing competency through self-paced and formal writing courses Become informed about the field Join a professional society like AMWA Attend local and national meetings Networking Find mentors (at meetings, LinkedIn, etc.) Request informational interviews Have your writing evaluated by professional writers Formal writing courses Self-paced learning (grammar, statistics & writing guides) Keep a science blog American Journal Experts (http://www.aje.com) Potential to earn a small wage in grad school/or postdoc while gaining writing/editing experience

Getting Started Professional documents Curriculum Vitae Science CV is not equal to the medical writing CV These documents highlight vastly different skills and experience Ask feedback from a professional medical writer Cover letter strategies Tailor to each specific position Clear, concise, error-free Attempt to address letter to a person Find HR rep for company via Linkedin at the very least Address the cover letter to Dear Hiring Manager if attempts to identify a specific contact fails Always print and proof read documents prior to submitting applications

Long-term Training Certificate, Undergraduate and Graduate Programs American Medical Writers Association (AMWA) University of Chicago University of the Sciences in Philadelphia Johns Hopkins University Tufts University School of Medicine University of California San Diego UCSD Extension School Many other professional programs Some programs offered online

Writing Samples Content produced in graduate school/postdoc Peer-reviewed journal articles Internship with medical communications company Maintain a science-related blog Produce content for a newsletter Take a medical writing course

Crooked Path to Medical Writing Strong life-long interest in writing Gravitated towards grant and report writing in graduate school Enjoyed writing manuscripts, presentations, patent and regulatory applications, protocols and SOPs when working as a scientist Motivation to transition from the bench Paid for a course and worked as a contractor for Emma Hitt, PhD. www.hittmedicalwriting.com Applied for and accepted medical writing positions

Scientific Career San Diego State University (B.S. 1999) Undergrad researcher at Scripps Research Institute Harvard Medical School (PhD Immunology 2006) Cell and molecular immunology (T cell biology) Pfizer, Inc. San Diego, CA (2007-2012) Transition away from the bench (2012)

Transferable Skills Skill Writing Computer skills Presentation skills Project management Project leadership and mentoring Team work Opinion leader experience Example Peer- reviewed journal manuscripts, dissertation, protocols, scientific presentations MS Office suit, graphing/statistics software, document formatting Lab and departmental meetings, scientific talks, job talks Development, execution and presentation of scientific projects Mentoring students, teaching/demonstrating Collaborating with colleagues and research groups Conversing with experts in your field

Formal Medical Writing Experience Hitt Medical Writing, LLC (sub-contractor) Projects: manuscripts, medical news, continuing medical education (CME) ScienceMedia, Inc. (full-time medical writer) Projects: Immunology and Oncology subject matter expert (SME) Allergan (Section Manager, Documentation & Archiving) Direct experience with regulatory writing NDAs, INDs, MAAs, IRFs, and IBs) non-clinical sections

Medical Writing Tests Power point presentation Based on a clinical or scientific paper Produce a white paper On a topic selected by the potential employer Create documents specified by the employer Section of a storyboard An introduction An abstract Time allowed 1 hour a couple of weeks depends on the employer

Medical Writing Tests Tests are not designed to: Test level of expertise in a specific scientific area Tests are developed to evaluate applicant s ability to: Write (spelling, grammar and flow) Follow instructions and meet timelines Interpret and assimilate information using materials and instructions provided for the test Some tests are completed: During the site interview At home Tips: Keep it simple, use short, familiar words, avoid jargon and acronyms, be specific and concrete; not abstract

Frequent Writing Problems Encountered by Editors Poorly written, excessive jargon Inadequate/inappropriate presentation Poor description of design Excessive zeal and self promotion Rationale confused, contradictory Essential data omitted, ignored Boring Important work of others ignored Seldom Occasionally Frequently Byrne DW, Publishing Medical Research Papers, Williams and Wilkins, 1998

On the Job Training Gain as much information about the assignment as possible Ask questions Develop a thick skin Work will be reviewed and critiqued by senior writers and clients Be prepared for rounds of revisions Be prepared for cuts, scope changes and shifting deadlines Focus on meeting or exceeding deadlines Get used to multiple competing projects Get used to not being the owner of the project

Benefits of Transitioning to a Career in Medical Writing Love of science x love of writing = interesting career Flexibility (as long as timelines are kept) Options for entrepreneur and employees Highly varied career options Highly lucrative career options Excellent use of scientific skills Writing is a creative endeavor Relevant work and exposure to latest information

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