Job Description

The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas (i.e. spine, trauma, and cranio-maxiofacial areas) and/or medical devices (mostly mechanical implants and instruments such as plates, screws, meshes, cages, etc.) in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. Note: I don’t think it is absolutely critical that the person has experience in these particular devices. It would be nice, but not absolutely necessary, as long as they have experience in mechanical type devices versus electrical / chemical / biological products. Also, many MDs would likely have a good appreciation of the therapeutic areas but if their specialties / experience is more pharmacological, they still don’t seem like the best fit. I also don’t think it is necessary to have an MD.

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 European law (i.e. Medical Device Directive (MDD), a.k.a. 93/42/EEC), procedures, internal and external guidelines (e.g. MEDDEV 2.7.1) – this is a key guidance document that I did not see once on the resumes, 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 side is minor & potentially negligible need in this business unit) 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.
• Performs MAUDE data base reviews
• Communicates with various departments (e.g. (European) Regulatory, Product Development (typically bioengineers or mechanical engineers), Clinical Research, Quality) to identify the necessary clinical and technical information.

Job Qualifications

Education
• Ph.D plus 1 to 2 years of related medical device experience (e.g. medical writing, regulatory affairs, clinical research, engineering)

• BS/BSN or MS plus 4 to 5 years of relevant medical device industry experience

Knowledge/Requirements

• Excellent English language skills, especially writing and proofreading.
• H1B Sponsorship available
• 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).