Senior Manager, Medical Writing

Role Overview

• Prepares and reviews clinical/regulatory documents to support all phases of drug development
• Leading the writing activities for all regulatory documents for a project team
• Identifying and managing contractors
• Planning activities for New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs)
• Building and managing the submission writing team
• Authors and manages the authoring process for all clinical/regulatory documents
• Leads and provides subject matter expertise to the core authoring team
• Ensures document content is clear, concise, strategic, and well positioned for public disclosure
• Supports authoring best practices and provides continued training to teams
• Represents Medical Writing Department on project teams
• Mentor and may manage internal staff

Requirements

• BS/BA degree in the life sciences or related field AND 8+ years of medical writing or related experience required
• Experience leading an NDA/MAA or authoring key documents supportive of either
• MS/MA degree in a life sciences or related field preferred AND 6+ years of experience as noted above
• PhD in a life sciences or related field preferred AND 4+ years of experience as noted above
• Previous managerial / functional management experience also required
• Excellent team player who can effectively navigate differing opinions and personalities
• Strong skills in leadership, communication and creativity
• Excellent project management skills, including managing simultaneous projects
• Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools
• General understanding of statistics
• Broad understanding of the medical writing processes, procedures, and systems

Benefits

• Retirement savings plan (with company match)
• Paid vacation
• Holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental and vision coverage