Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Senior Medical Writer – Medical Device, Regulatory Documents
Location
Maine + 4 moreAll locations: Maine, Montana, North Carolina, Rhode Island, Washington
Posted
120 days ago
Salary
$80.6K - $145K / year
Seniority
Senior
Job Description
Job Requirements
- Leads the clear and accurate completion of medical writing deliverables
- Manages medical writing activities associated with individual studies
- Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments
- Adheres to established regulatory standards, including ICH E3 guidelines
- Coordinates quality and editorial reviews
- Reviews statistical analysis plans and table/figure/listing specifications
- Interacts and builds good working relations with clients, department head, and peers in data management
- Mentors and leads less experienced medical writers
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
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