Sr. Manager, Medical Writing

Prepares and reviews clinical/regulatory documents to support all phases of drug development by leading the writing activities of an interdisciplinary team to develop documents that are concise, high quality, and comply with internal and external standards.

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 (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc) is highly preferred
• Proven ability to lead cross-functional teams through the authoring process
• Excellent team player who can effectively navigate differing opinions and personalities
• Strong skills in leadership, communication and creativity
• Able to work well both independently and as part of a team
• Excellent project management skills, including managing simultaneous projects
• Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools
• Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses
• Strong science background that enables the ability to interpret and communicate scientific and clinical trial data
• General understanding of statistics
• Broad understanding of the medical writing processes, procedures, and systems used to accomplish the team’s work

Benefits

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