Job Title – Technical Writing Consultant
Job Location – Colorado Springs CO
Length – Contract (8 Months)
- 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.
Experience: A minimum of 5 years of clinical or industry experience preferably supporting activities in clinical research, medical affairs or similar experience in a medical/scientific area is required .
Education: Bachelors/Masters in a scientific/technical discipline or equivalent; advance degree (M.S., Ph.D.) desired, experience in pharmaceutical, biological, or medical device development , Experience writing regulatory submissions such as NDAs/INDs,BLAs , Strong knowledge of FDA, ICH, ands GCP guidelines, Regulatory/Clinical writing experience,
APN Software Service INC