Senior Medical Writer - CER & Regulatory Submissions

Techlink Systems Inc.; Maple Grove (MN); On-site; USD 95,000 - 125,000; Full time

Job summary

Techlink Systems Inc. in Maple Grove, MN (onsite) seeks an experienced Medical Writer IV to develop Clinical Evaluation documentation and support regulatory submissions.

The role operates on a daytime schedule under a contract ending 10/15/2027, with an on-site work arrangement. The candidate should have 6-8 years of medical writing experience in the medical/pharmaceutical sector or 8+ years in technical writing, and possess strong communication and collaboration skills.

Qualifications

• Bachelor's Degree or equivalent required.
• 6-8 years medical writing experience in the medical or pharmaceutical industry or 8+ years general technical writing experience required.
• Experience with clinical, regulatory, quality and medical device documentation.

Responsibilities

• Writes and contributes to Clinical Evaluation reporting deliverables including CERs, CEPs and regulatory responses.
• Evaluates and summarizes clinical evidence from literature, investigations, PMS and post-market data.
• Collaborates with cross-functional teams on CER-related projects and processes.
• Supports regulatory, quality and engineering deliverables as assigned.
• Communicates with Sales, Marketing, R&D, Regulatory Affairs and other groups to complete CER-related deliverables.
• Maintains knowledge of assigned products and interprets data from various sources.
• Reviews IFUs, patient guides and risk files for alignment of risk information and regulatory inquiries.
• Authors documents for regulatory submissions and risk reviews.

Skills

Communication skills

Analytical skills

Time management

Cross-functional teamwork

Education

Bachelor's degree

Biomedical/health sciences preferred

Tools

Word

Excel

PowerPoint

Outlook

Job description

Techlink Systems Inc. in Maple Grove, MN (onsite) seeks an experienced Medical Writer IV to develop Clinical Evaluation documentation and support regulatory submissions.

The role operates on a daytime schedule under a contract ending 10/15/2027, with an on-site work arrangement. The candidate should have 6-8 years of medical writing experience in the medical/pharmaceutical sector or 8+ years in technical writing, and possess strong communication and collaboration skills.