INTELLECTT INC is hiring: Medical Writer in Maple Grove

Role: Medical Writer II

Location: Maple Grove, MN - 55311 (100% Onsite)

Duration: 12 Months

Shift: 8 AM to 5 PM

Key Responsibilities:

• Author Clinical Evaluation Reporting (CER) documents for Neuromodulation, CAHF, and Vascular products.
• Write and review deliverables like Clinical Evaluation Plans/Reports, PMS/PMCF Plans/Reports, SSCPs, and Regulatory Responses.
• Summarize clinical evidence from clinical investigations, literature, post-market surveillance, and risk data for product applications and submissions.
• Collaborate with stakeholders across departments for CER-related projects.
• Maintain expertise on assigned products and source, interpret, and evaluate data from various references.
• Review materials such as IFUs, Risk Management files, and training documents to ensure alignment and compliance.
• Support regulatory submissions, risk reviews, and responses to complex inquiries.
• Ensure documentation meets quality standards and adheres to applicable regulations (ISO13485, ISO14155, MEDDEV 2.7.1, MDR, FDA guidelines, etc.).

Qualifications:

Required:

• Bachelors degree or equivalent experience.
• 4-6 years of medical writing experience in the medical or pharmaceutical industry, or 7+ years of general technical writing experience.
• Experience in medical, pharmaceutical, clinical research, or related fields.

Preferred:

• Background in biomedical sciences, medicine, or health-related fields.
• Clinical Evaluation Report (CER) writing experience.
• Strong communication, analytical, and time management skills.
• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.
• Experience working in collaborative, cross-functional teams.