Associate Director / Director, Medical Writing

Role Summary

Beam is seeking a highly talented and motivated AD/Director to join our growing Medical Writing team. The AD/Director will be responsible for creating, authoring, and leading the management of key documents for regulatory filings and clinical studies, such as clinical protocols and amendments, clinical study reports, investigator’s brochures, safety and efficacy summaries, and other documents required for regulatory submissions. Working across functions such as clinical operations, regulatory affairs, medical, biostatistics, and pharmacovigilance, this role will represent Medical Writing on study teams and will report to the VP of Medical Writing.

Responsibilities

• 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.

Qualifications

• 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.
• Gene therapy experience is preferred but not required.
• 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.