Our client is looking for a CER Medical Writer for a 9-12 month contract. This person will be responsible for supporting the development and creation of clinical, scientific, and regulatory documents in accordance with procedures, European Medical Device Regulations, and US FDA requirements. The primary focus will be on Clinical Evaluation Reports (CERs) and Summaries of Safety and Clinical Performance (SSCPs).
- With minimal oversight, researches, prepares, writes, edits and reviews clinical evidence documents, e.g. CERs and SSCPs.
- Conducts proofreading, editing, document formatting, review comment integration, and document completion/approval activities.
- Supports the regulatory approval process through clinical evidence document formulation and responding to regulatory agency questions.
- Collaborates with cross-functional teams to ensure high quality and successful project delivery.
- Develops and maintains in-depth therapeutic and product operation knowledge; applies this knowledge to the development of well written clinical evidence documents.
- Provides input to post-market surveillance and risk management activities.
- Creates and manages a schedule of deliverables.
- Performs other duties and tasks, as required.
- Education: Bachelors’ degree in the medical, biological, physical, or engineering disciplines and three years of medical writing experience, preferably with CERs.
- Knowledge of regulatory requirements relative to Clinical Evaluation Reports.
- Experienced in searching medical literature and databases for clinical and technical information.
- Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information and complex documents.
- Knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), EU Medical Device Regulation (2017/745) and ISO 13485 Quality System Standards.
- Effective written and verbal communication skills in the area of technical/clinical applications.
- Strong command of medical and surgical terminology.
- Working knowledge of statistics.
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Project management skills.
- Demonstrated computer skills preferably spreadsheets, word processing, internet research, and other applicable software programs.
- Medical/technical writing skills
- CER protocol and report development/writing
- Medical literature research skills
- Computer skills
- Interpersonal/verbal/written communication skills
- Project management skills
- Statistical knowledge/application
Remote: CER Medical Writer (230894)