Medical Device Medical Writer (CER Specialist)
Celegence is seeking a Medical Writing Specialist to join our consulting team in support our expanding list of Medical Device clients. The consultant will be responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the clients Strategic Medical Affairs Team for a wide range of audiences.
Roles & Responsibilities
- 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.
- 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.
- Strong understanding of EU MDR
Education & Experience
- BS Degree minimum—Masters Degree or PhD a plus.
Skills and Competencies
- Experience writing CERs (start to finish)
- Scientific/clinical background
- Medical writing
- Understanding of statistical analysis
- Hands on person with problem-solving attitude
- Strong verbal and written communication skills in English, ability to influence others, and strategic thinking
- Customer focused
- Organized, thoughtful, and positive