Medical Writer II
Part-time role, 20 hours per week (8:00 AM to 12:00 PM), 100% onsite in Little Canada, MN.
About the role
Author and update clinical evaluation documents, including Clinical Development Plans (CDPs), PMCF Plans, and Evaluation Reports, ensuring compliance with EU MDR requirements. Collaborate with clinical, risk evaluation, regulatory, and quality teams to develop high-quality, regulatory-compliant clinical evidence documentation. Review clinical evaluation documents for scientific and clinical accuracy, consistency, and data integrity. Support development of clinical study protocols, statistical analysis plans, and study reports as needed. Maintain thorough knowledge of supported products and interpret clinical data to inform benefit-risk assessments and regulatory submissions.
Requirements
- Bachelor’s degree in Science, Medical Technology, or a related field.
- Minimum of 3 years of experience in clinical research, medical writing, or related healthcare industry roles.
- Familiarity with PMCF requirements, EU MDR, and clinical evaluation processes.
Pay
$43 to $48 per hour on W2.
Benefits
Upon completion of waiting period, consultants are eligible for:
- Medical and prescription drug plans
- Dental plan
- Vision plan
- Health Savings Account
- Health Flexible Spending Account
- Dependent Care Flexible Spending Account
- Supplemental life insurance
- Short-term and long-term disability insurance
- Business travel insurance
- 401(k) plan with company match
- Weekly pay