Senior Medical Writer

CooperCompanies

Senior Medical Writer developing clinical and regulatory documents for CooperSurgical. Collaborating cross-functionally to ensure compliance with global standards and regulatory requirements.

Posted 5/8/2026full-timeRemote • Connecticut • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

- 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

Requirements

What you’ll need

- **Knowledge, Skills, and Abilities:**
- 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
- **Experience:**
- Preferred 5-10 years of experience in medical writing for medical devices, including CERs and PMCF documentation.
- **Education:**
- Master’s degree in Life Sciences or related field preferred.

Benefits

Comp & perks

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.

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical writingclinical evaluation reportsliterature reviewsregulatory submissionsclinical data collectionEU MDR complianceFDA regulationsISO standardsmedical writingdata interpretation

Soft Skills

written communicationverbal communicationanalytical mindsetdetail-orientedorganizedresults-driven