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

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