Senior Principal Medical Writer – Regulatory, Oncology

Job Description: • Develop regulatory documents for submission to regulatory agencies globally • Manage medical writing projects, including developing timelines and communication with cross-functional team members • Participate in cross-functional meetings to provide input regarding medical writing deliverables • Review other documents associated with the assigned project(s) • Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents • Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects • Mentor more junior medical writing staff Requirements: • Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes • Manage medical writing projects, including developing timelines and communication with cross-functional team members • Participate in cross-functional meetings to provide input regarding medical writing deliverables • Review other documents associated with the assigned project(s) • Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents • Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects • Mentor more junior medical writing staff

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

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