What are the responsibilities and job description for the Medical Writer Senior Specialist position at CooperSurgical?
Job Description
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.
Responsibilities
Essential Functions & Accountabilities:
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
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.
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.
Responsibilities
Essential Functions & Accountabilities:
- 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
- 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.
- Our Benefits :
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
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.