Medical Writer Specialist
CooperCompanies, Trumbull, CT, United States
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.
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.
Qualifications 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
Outgoing, positive, and collaborative with a good sense of humor
Experience:
Preferred 1‑5 years of experience in medical writing for medical devices, including CERs and PMCF documentation.
Education:
Bachelors degree in Life Sciences or related field required. Master’s degree in Life Sciences or related field preferred.
Remote
Benefits As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. 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. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
Equal Opportunity We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com.
Job Info
Job Identification 10835
Job Category Marketing
Posting Date 04/08/2026, 05:06 PM
Job Schedule Full time
Job Shift Day
Locations Trumbull, CT, United States (On-site)
#J-18808-Ljbffr
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.
Qualifications 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
Outgoing, positive, and collaborative with a good sense of humor
Experience:
Preferred 1‑5 years of experience in medical writing for medical devices, including CERs and PMCF documentation.
Education:
Bachelors degree in Life Sciences or related field required. Master’s degree in Life Sciences or related field preferred.
Remote
Benefits As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. 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. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
Equal Opportunity We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com.
Job Info
Job Identification 10835
Job Category Marketing
Posting Date 04/08/2026, 05:06 PM
Job Schedule Full time
Job Shift Day
Locations Trumbull, CT, United States (On-site)
#J-18808-Ljbffr