Independently 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 regulatory approval process through clinical evidence document formulation and responding to regulatory agency questions.
Manages and maintains the procedures, systems and processes required to meet regulatory requirements for clinical evidence documents and ensures they stay up-to-date based on guidance, regulation and feedback from regulators.
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 schedule of deliverables.
Conducts training for medical writers, regulatory affairs and other functions, as needed.
May supervise or mentor other medical writers, as assigned.
Performs other duties and tasks, as required.

Education and/or experience equivalent to a Bachelor’s Degree in the medical, biological, physical or engineering disciplines and five years of medical writing experience, preferably with CERs.
Extensive knowledge of regulatory requirements relative to Clinical Evaluation Reports.
Proficient 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.
Supervisory experience.
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.

Senior Medical Writer

Key skills