Medical Writer III Job at Abbott in Maple Grove
Abbott - Maple Grove, MN, United States, 55311
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Overview
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Overview
Our location in Maple Grove, MN, currently has an opportunity for a Medical Writer III. The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and lifecycle process. Daily activities involve authoring Clinical Evaluation Reporting documents for Neuromodulation, CAHF, and Vascular products.
Title: Medical Writer III
Location: Maple Grove, MN
Duration: 6-12 Months (possibility of conversion to hire)
Work Arrangement: 100% Onsite
Responsibilities:
- Author and contribute to Clinical Evaluation reports, including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses, and related documentation.
- Evaluate and summarize clinical evidence from investigations, literature, post-market surveillance, and clinical evaluations, analyzing results for product submissions.
- Collaborate with team members and stakeholders on CER projects and processes.
- Support additional clinical, regulatory, quality, and engineering deliverables as assigned.
- Communicate effectively with Sales & Marketing, R&D, Regulatory Affairs, and other departments to complete clinical evaluation deliverables.
- Maintain thorough knowledge of products, source relevant data, and interpret information from various sources.
- Review IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, and Reports for consistency and risk information alignment.
- Prepare documents for regulatory submissions, responses, and inquiries.
- Ensure quality, accuracy, and compliance with applicable standards and regulations (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, FDA, and EU guidance).
Key Success Factors:
- Experience in clinical study management, scientific or medical writing, or quality engineering/risk management.
- Strong communication skills.
- Experience working with cross-functional teams.
Qualifications:
- Bachelor’s Degree in biomedical sciences, medical technology, or related field.
- 6-8 years of medical writing experience in the medical or pharmaceutical industry, or 8+ years of technical writing experience.
- Experience in medical, pharmaceutical, medical device, or clinical research industries.
- CER writing experience preferred.
- Excellent analytical skills, ability to manage complex tasks and time effectively.
- Proficient with Word, Excel, PowerPoint, Outlook.
Benefits:
- Medical, dental, vision plans.
- Health Savings Account and Flexible Spending Accounts.
- Life insurance, short-term and long-term disability.
- Critical illness, hospital, and accident insurance.
- Legal, ID theft, and pet insurance.
- 401(k) plan.
Abbott is a global healthcare leader dedicated to improving health and well-being through innovative technologies across diagnostics, medical devices, nutrition, and medicines.
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