Senior Principal Medical Writer – Publication Strategy, Planning
Job Description:
- 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
Apply tot his job Apply To this Job