Senior Director, Medical Writing

Ironwood Pharmaceuticals is seeking a Senior Director of Medical Writing to lead the development of high-quality clinical and regulatory documents to advance company goals. The ideal candidate will have 12+ years of medical writing experience in the pharmaceutical or biotech industry, with experience managing resources and leading medical writing teams responsible for global marketing authorization applications.

Requirements

• BA/BS and 12+ years of medical writing experience in the pharmaceutical or biotech industry
• Advanced degree preferred
• Success in managing resources (internal, external, or hybrid)
• Prior direct experience leading medical writing teams responsible for global marketing authorization applications
• Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle
• Strong understanding of the drug development process, including regulatory requirements and ICH/GCP/eCTD guidelines.
• Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology
• Excellent technical writing and editorial skills; excellent attention to detail
• Strong ability to understand and interpret medical and scientific data
• Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint
• Experience with automated document templates (e.g., StartingPoint by Accenture), Adobe Acrobat and EndNote
• Excellent communication, interpersonal, and organizational skills
• Experience working on cross-functional teams
• Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines

Benefits

• Comprehensive compensation and benefits program
• Restricted Stock Unit awards
• Bonus or sales incentive program
• Company-sponsored 401(k) with matching contributions
• Medical, dental, vision, and prescription drug benefits
• Wellness stipends
• Generous vacation/holiday schedule