Medical Writer Senior Specialist

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.

About CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.

As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments.

Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond.

We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions.

Learn more at www.coopersurgical.com.

Work location: Trumbull, CT, Livingston, NJ, or remote.