Medical Writer II (Contract)

$83,200 - $93,600/Yr

Blue Star Partners - Maple Grove, MN

posted about 2 months ago

Full-time
Maple Grove, MN
General Merchandise Retailers

About the position

The Medical Writer II position is focused on authoring Clinical Evaluation Reporting (CER) documents for various medical products, including those related to Neuromodulation, Cardiac Arrhythmias & Heart Failure, and Vascular products. This role requires collaboration with cross-functional teams to ensure that all documentation meets regulatory standards and internal quality guidelines. The position is fully onsite in Maple Grove, MN, and emphasizes high-quality documentation and compliance with relevant regulations.

Responsibilities

  • 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.
  • Analyze and summarize clinical evidence from various sources, including clinical investigations, literature reviews, risk management files, and post-market data.
  • 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.
  • 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).
  • Maintain high-quality standards for all deliverables, ensuring consistency in data interpretation, alignment of risk information, and adherence to corporate and divisional procedures.
  • Stay informed on assigned products, understand clinical and technical data, and ensure that clinical evidence and documentation reflect current product performance and risk assessments.

Requirements

  • Bachelor's degree or equivalent combination of education and 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.

Nice-to-haves

  • 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.
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