Medical Writer II

Job Title: Medical Writer II

Location: Maple Grove, MN (100% Onsite)

Rate: $40 - $45/hr

Duration: 1 Year

Hours:

40 Hours/Week

Contact Type: W2 (must be authorized to work in the U.S.; no sponsorship or C2C)

We are seeking a Medical Writer II to join our client's team in Maple Grove, MN. This role focuses on authoring Clinical Evaluation Reporting (CER) documents for Neuromodulation, Cardiac Arrhythmias & Heart Failure (CAHF), and Vascular products. The Medical Writer II will collaborate with multiple cross-functional teams to develop, evaluate, and finalize a variety of clinical and regulatory documents. This position is fully onsite and will ensure that all documentation adheres to applicable regulations, guidelines, and internal quality standards.

• Document Authoring: Write and contribute to clinical evaluation reports, plans, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) reports, summary of safety and clinical performance (SSCP) documents, and regulatory responses.
• Data Evaluation: Analyze and summarize clinical evidence from various sources, including clinical investigations, literature reviews, risk management files, and post-market data.
• Cross-Functional Collaboration: Partner with Sales, Marketing, R&D, Regulatory Affairs, Product Performance Group, Quality Engineering, Clinical Affairs, Clinical Science, Risk Management, and Medical Affairs to ensure comprehensive and accurate CER-related outputs.
• Regulatory Alignment: Participate in responses to complex regulatory queries, address notified body comments, and ensure documentation compliance with relevant regulations (ISO 13485, ISO 14155, ISO 14791, MEDDEV 2.7.1, MDR, EU/FDA guidance).
• Quality & Consistency: Maintain high-quality standards for all deliverables, ensuring consistency in data interpretation, alignment of risk information, and adherence to corporate and divisional procedures.
• Knowledge Maintenance: Stay informed on assigned products, understand clinical and technical data, and ensure that clinical evidence and documentation reflect current product performance and risk assessments.

• Education: Bachelor’s degree or equivalent combination of education and experience.
• Experience:
• 4-6 years of medical writing experience in the medical or pharmaceutical industry, or
• 7+ years of general technical writing experience in related fields.
• Demonstrated experience in clinical study management/design, medical writing, scientific writing, and/or quality engineering/risk management.

• Degree in biomedical, sciences, medicine, or similar health-related discipline.
• Prior CER writing experience is highly preferred.
• Strong analytical skills and ability to manage complex tasks efficiently.
• Proficiency in MS Word, Excel, PowerPoint, and Outlook.
• Familiarity with collaborative, cross-functional teams and regulated industry environments.
• Excellent written and verbal communication skills and ability to meet project deadlines.