Senior Medical Writer – Medical Device, Regulatory Documents

Job Description: • Leads the clear and accurate completion of medical writing deliverables • Manages medical writing activities associated with individual studies • Completes documents that may include clinical study protocols, clinical study reports, and informed consents • Adheres to established regulatory standards and company procedures • Coordinates quality and editorial reviews • Acts as peer reviewer for internal team • Provides feedback to define statistical output required • Performs online clinical literature searches • Mentor and lead less experienced medical writers 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 Apply tot his job Apply To this Job