Associate Director / Director, Medical Writing

• Act as lead writer for clinical regulatory documents for the hematology program
• Plan and lead the development of clinical study documents, working with cross-functional colleagues
• Work closely with the regulatory team and other writers on regulatory document submissions
• Assist with developing and maintaining medical writing process documents
• Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
• Contribute to statistical output plans concerning organization and table layout for specific documents
• Project management, strategic design, planning, team input, and reviews
• Opportunities for management/mentorship of other writers

• Bachelor’s degree required
• MS, PharmD, or PhD preferred in a life science or health discipline
• 12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
• A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
• Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
• Excellent communication skills, both oral and written
• Ability to build strong relationships and work collaboratively across functions
• Effective organizational and meeting skills and attention to detail
• Experience with workflow management within standard document management systems
• Ability to come onsite when needed such as for important meetings and team/company functions

Gene therapy experience is preferred but not required