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

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