Sr. Medical Writer at Horizontal Talent in Maple Grove, Minnesota

Job Description:

Our client is seeking a dedicated Sr. Medical Writer to join their Regulatory Clinical Evaluation team. This role is integral to the product development and life cycle process, focusing on authoring Clinical Evaluation Reporting documents for Neuromodulation, CAHF, and Vascular products.

Key Responsibilities:
- Write and contribute to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses, and other related documentation.
- Evaluate and summarize clinical evidence from various sources such as clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations.
- Collaborate with team members and stakeholders in planning for and supporting CER related projects and processes.
- Support additional clinical, regulatory, quality, and engineering-related deliverables as assigned.
- Maintain thorough knowledge of assigned products and identify appropriate sources of relevant data.
- Author and contribute to necessary documents for regulatory submissions and communications, risk reviews, and other processes such as regulatory inquiries.

The ideal candidate will have 4-6 years of medical writing experience in the medical or pharmaceutical industry or 7+ years of general technical writing experience. A Bachelor's Degree or an equivalent combination of education and work experience is required. Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management is essential.

Preferred Qualifications:
- Biomedical, sciences, medicine, or similar health-related discipline.
- CER writing experience.
- Excellent analytical skills and ability to manage complex tasks and manage time effectively.
- Proficient with Word, Excel, PowerPoint, Outlook, etc.

Our client's team is committed to creating innovative technologies that are faster, more effective, and less invasive. Join us in our mission to improve the quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.