Overview:
The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the Client Strategic Medical Affairs Team for a wide range of audiences.
Key Job Activities:
- Primarily focuses on preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to regulatory authorities (e.g. notified bodies).
- Participates in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
- Performs scientific writing (e.g. abstracts, manuscripts, presentations).
- Organizes and incorporates information for documents, such as references, graphics, tables, and data listings.
- Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1), and electronic templates.
- Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence
- Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
- Reviews and provides input on clinical data being considered for presentation and/or publication to ensure alignment with scientific strategies and corporate goals.
- Expert knowledge of clinical research, device/drug development processes, regulatory requirements, good clinical and data management practices.
- Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users.
- Communicates with various departments (e.g. Regulatory, Product Development, Clinical Research, Quality) to identify the necessary clinical and technical information.
Job Qualifications
Education
- Ph.D/Pharm D plus 1 to 2 years of related medical device/drug industry experience (e.g. medical writing, regulatory affairs, clinical research, engineering)
- BS/B.Pharm/BSN or MS or MPH plus 4 to 5 years of relevant medical device/drug industry experience
Knowledge/Requirements
- Excellent English language skills, especially writing and proofreading.
- Clinical, scientific or research background, highly preferred.
- Experience writing CERs, highly preferred.
- Knowledge in narrative or systematic literature reviews (e.g. PRISMA, Cochrane), highly preferred.
- Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines, preferred.
- Expert understanding of scientific or clinical research and methods.
- Understanding of statistical data and good data management practices.
- Strong oral communication, presentation, project management and prioritization skills.
- Excellent interpersonal relationships.
- Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager).
Contact me at 732 549 5307
