Medical Writer Senior Specialist

CooperCompanies • Trumbull, CT

21h

About The Position

The Senior Medical Writer is responsible for developing, writing, and managing high-quality clinical and regulatory documents that support compliance and product lifecycle needs for global standards such as EU MDR and FDA regulations. This includes planning, implementing, and reporting clinical data collection for Post-Market Clinical Follow-up (PMCF) and clinical trials, ensuring adherence to global regulatory standards. The role collaborates cross-functionally to maintain clinical documentation within the Quality Management System and stays current with scientific literature and regulatory requirements.

Requirements

• Strong understanding of EU MDR, FDA regulations, and ISO standards for medical devices.
• Proficiency in document management systems and Microsoft Office Suite
• Excellent written and verbal communication skills
• Ability to interpret clinical data and present findings clearly
• Analytical mindset
• Detail-oriented, organized, and results-driven
• Preferred 5-10 years of experience in medical writing for medical devices, including CERs and PMCF documentation.

Nice To Haves

• Master’s degree in Life Sciences or related field preferred.

Responsibilities

• Author and edit clinical documents, including Clinical Evaluation Reports (CERs), literature reviews, and regulatory submissions.
• Plan and report clinical data collection for PMCF and clinical trials nationally and internationally.
• Ensure clinical documentation compliance with EU MDR, FDA, and other international regulatory requirements.
• Collaborate with Global Regulatory & Clinical Affairs teams to maintain clinical documentation within the Quality Management System.
• Stay updated on scientific literature and regulatory changes within the company’s therapeutic area.
• Participate in cross-functional projects and contribute to clinical strategy and documentation planning.
• Support Medical Affairs for literature reviews and writing of documentation

Benefits

• As an employee of CooperSurgical, you'll receive an outstanding total compensation plan.
• As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level