Medical Writer Senior Specialist
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Job Location:
Trumbull, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Department:
Job Summary
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 companys 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
Experience:
Preferred 5-10 years of experience in medical writing for medical devices including CERs and PMCF documentation.
Education:
Masters degree in Life Sciences or related field preferred.
Our Benefits:
As an employee of CooperSurgical youll 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. Please visit us atto learn more about CooperSurgical and the benefits of becoming a member of our team.
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 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.
Required Experience:
Senior IC
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
Live Brightly. Our daily and monthly soft contact lenses are designed with your health and comfort in mind. For every eye, every person, and every day.
