Principal Medical Writer
Parexel
Senior Principal Medical Writer – Publication Strategy, Planning
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • Maine, Montana, Rhode Island, Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $95,000 - $175,700 per year
Job Level
Senior
About the role
- Leads the clear and accurate completion of complex medical writing deliverables
- Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments
- Adheres to established regulatory standards
- Advises clients and study teams on data presentation and production strategies
- Leads team document reviews and reviews documents for technical issues
- Performs online clinical literature searches and complies with copyright requirements
Requirements
- Leads the clear and accurate completion of complex medical writing deliverables
- Completes a variety of documents that may include clinical study protocols and amendments
- Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines
- Advises clients and study teams on data presentation and production strategies
- Serves as expert peer reviewer for internal team
- Reviews statistical analysis plans and table/figure/listing specifications
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingclinical study protocolsstatistical analysis planstechnical document reviewdata presentation strategiesliterature searchesregulatory standardsICH E3 guidelines
Soft skills
leadershipadvisory skillsattention to detailcommunication
