I hope this email finds you well. I am reaching out to inform you of an exciting opportunity for a Medical Writer position located in Maple Grove, MN. This role offers the chance to work on clinical evaluation reports and other related deliverables for Neuromodulation, CAHF, and Vascular products. The position is 100% onsite and will last for 12 months from the start date.

Key Responsibilities:

• Writing and contributing to Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, and Regulatory Responses.
• Evaluating clinical evidence from various sources, including clinical investigations, literature, and post-market surveillance, to analyze results for product submissions.
• Collaborating with cross-functional teams including Sales and Marketing, R&D, Regulatory Affairs, Clinical Affairs, and Medical Affairs.
• Ensuring quality and compliance with applicable regulations and standards (ISO13485, ISO14155, ISO14791, MDR, EU, FDA).

Requirements:

• Bachelor's Degree or equivalent experience, with 4-6 years of medical writing experience, or 7+ years of technical writing experience.
• Experience in medical, pharmaceutical, or clinical research writing is highly preferred.
• Strong communication, analytical, and time management skills are essential.
• Proficiency in Word, Excel, PowerPoint, and Outlook is required.

Preferred:

• Experience with Clinical Evaluation Reporting (CER) and working with cross-functional teams is a plus.
• A background in Biomedical Sciences, Medicine, or a similar health-related discipline would be advantageous.

If you are interested in discussing this opportunity further, please feel free to reply to this email with your availability for a brief conversation. We would love to explore how your experience aligns with this position.

Thank you for considering this opportunity, and I look forward to hearing from you soon.