Type: Contract
Hours per week: 40
Location: Maple Grove, MN
Summary: Drive clinical reporting processes and ensure compliance for medical device products.
Role Overview:
As a Sr. Medical Writer, you will deliver high-quality clinical documentation to support regulatory submissions and product life cycle management.
Day in the Life:
- Write and contribute to Clinical Evaluation Reports, Plans, and related regulatory documents.
- Summarize and analyze clinical evidence, including data from investigations, literature, and post-market surveillance.
- Collaborate with cross-functional teams to meet clinical evaluation project objectives.
- Support regulatory inquiries, risk reviews, and product documentation development.
- Ensure compliance with relevant standards and regulatory guidelines.
Your Qualifications:
- Bachelor’s degree or equivalent education/work experience required.
- 4-6 years of medical writing experience in medical or pharmaceutical industries.
- Strong understanding of CER writing and regulatory guidelines (ISO13485, MDR, etc.).
- Proficiency with Microsoft Office Suite.
- Exceptional analytical, written, and verbal communication skills.
To ensure your application is reviewed quickly, please include the phrase “creating happy careers” in the “Additional How Did You Find Us?” text box.
What We Believe In:
Celarity believes a key part of creating happy careers is first creating inclusive connections for ALL talent through exposure and access.
Celarity knows the importance of providing exposure, access, and equitable opportunities and is on a mission to connect open, qualified, and available candidates to careers in the Marketing, Creative, Digital, Operations, Human Resources, and Financial industries.
Celarity is an Equal Opportunity Employer. For Celarity, it’s about the quality of relationships through ethical business practices. We have a responsibility to employees, clients, and the community. Hiring decisions are made without regard to: Race • color • creed • religion • national origin • gender • age • marital status • disability • public assistance status • veteran status • sexual orientation or any other characteristic protected by federal, state, or local laws.
