Blue Star Partners LLC
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) Job Description
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. Key Responsibilities
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. Required Qualifications
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. Preferred Qualifications
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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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) Job Description
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. Key Responsibilities
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. Required Qualifications
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. Preferred Qualifications
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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