Job Title

• Principal Medical Writer

Position Description

• Will be responsible for the preparation of clinical documents for worldwide submissions to regulatory authorities and for leading medical writing teams assembled to support large projects. 
• Will support Managers within Medical Communications by providing technical guidance to junior members of the department.

Position Responsibilities

• Independent preparation of clinical study reports, integrated clinical summaries, overviews, and other regulatory documents on investigational drugs in various stages of clinical development.
• Lead medical writing teams assembled for large projects, e.g. submissions; coordinate and direct work of internal or external medical writers assigned to the writing team.
• In conjunction with Director and MedCom Managers, will coordinate resource allocation and identify projects that exceed capacity of internal Medical Writing staff.  
• Will serve as liaison between outside writing sources and will review documents prepared by those outside resources.
• Will serve as department’s representative for assigned therapy team/working groups; and will participate in determining submission-level timelines.
• Will review, update and communicate the operational and functional procedures utilized by the department with regard to document creation, review, quality control and publishing/archiving. 
• Will also serve as a technical expert for the department and represent the department in cross-functional decision making teams and committees.

Position Requirements

• An advanced degree in Life Sciences – PhD or PharmD preferred.
• 10 plus years in Pharmaceutical Research & Development, with at least 5 of those years in Senior-Level Medical Writing.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance