Medical Writer Specialist

CooperCompanies•Trumbull, CT

3d•Remote

About The Position

The 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 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
Outgoing, positive, and collaborative with a good sense of humor
Bachelors degree in Life Sciences or related field required.
Preferred 1-5 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.
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