Senior Medical Writer

📋 Description

• Conducts independent research, preparation, writing, editing, and review of clinical evidence documents, such as Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCPs).

• Engages in proofreading, editing, document formatting, integrating review comments, and overseeing document completion and approval processes.

• Facilitates the regulatory approval process by creating clinical evidence documents and addressing inquiries from regulatory agencies.

• Oversees and updates the procedures, systems, and processes necessary to comply with regulatory requirements for clinical evidence documents, ensuring adherence to guidance, regulations, and feedback from regulators.

• Works collaboratively with cross-functional teams to ensure the successful delivery of high-quality projects.

• Develops and sustains comprehensive knowledge of therapeutic areas and product operations, utilizing this expertise to produce well-crafted clinical evidence documents.

• Contributes to post-market surveillance and risk management initiatives.

• Establishes and manages a schedule for deliverables.

• Provides training for medical writers, regulatory affairs personnel, and other functions as needed.

• May supervise or mentor other medical writers as assigned.

• Executes additional duties and tasks as required.

⛳️ Requirements

• Education and/or experience equivalent to a Bachelor’s Degree in medical, biological, physical, or engineering fields along with five years of medical writing experience, preferably involving CERs.

• In-depth understanding of regulatory requirements pertaining to Clinical Evaluation Reports.

• Skilled in researching medical literature and databases to gather clinical and technical information.

• Capable of reading, analyzing, and interpreting regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documentation.

• Familiarity with 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.

• Strong written and verbal communication skills in technical and clinical applications.

• Experience in a supervisory role.

• Proficient in medical and surgical terminology.

• Basic knowledge of statistics.

• Self-motivated and self-directed, with a keen attention to detail and exceptional time management skills.

• Possesses project management capabilities.

• Demonstrates computer skills, preferably in spreadsheets, word processing, internet research, and other relevant software applications.

🏝️ Benefits

• Multiple shifts and hours available: Days, Swing (Evening), and Nights.

• Medical, Dental, and other insurance options (eligible the first of the month after 30 days).

• Low-cost onsite medical clinic.

• Two onsite cafeterias.

• Employee garden and gardening classes.

• Three weeks of vacation, one week of sick time, and paid holidays.

• 401K and Health Savings Account.