Director, Medical Writing

PepGen - Boston, MA

Full-time - Senior

Boston, MA

Chemical Manufacturing

About the position

Working with the PepGen Team you will lead the development of regulatory and clinical documents, including (but not limited to) drafting scientific meeting briefing books, Protocols, Investigator's Brochures, annual reports, clinical and non-clinical reports, regulatory briefing documents, and clinical /nonclinical sections of IMPDs, INDs, CTAs, and NDAs. Your expertise and in-depth knowledge of analysis and presentation of scientific and clinical data will produce high-quality documents. As PepGen's first full-time Medical Writer employee, you will lead the development of Medical Writing departmental processes, procedures, and tools, providing the framework to deliver high-quality documentation. As an integrated team member, you will contribute to cross-functional working groups as needed to facilitate efficient development and finalization of regulatory and clinical documents for submissions.

Responsibilities

• Lead the development of regulatory and clinical documents.
• Draft scientific meeting briefing books, Protocols, Investigator's Brochures, annual reports, clinical and non-clinical reports, regulatory briefing documents, and clinical/nonclinical sections of IMPDs, INDs, CTAs, and NDAs.
• Develop Medical Writing departmental processes, procedures, and tools.
• Contribute to cross-functional working groups to facilitate efficient development and finalization of documents.

Requirements

• Bachelor's degree at a minimum, preferably a PhD in a Life Science area (or equivalent experience) with 5+ years of regulatory medical writing experience.
• Outstanding written and verbal communication skills.
• Well-organized with significant knowledge of drug development, clinical research, study design, biostatistics, and the regulatory environment.
• Detailed understanding of requirements for the preparation of key clinical and regulatory documents.
• Independently motivated with good problem-solving ability; able to work with multiple contributors.

Nice-to-haves

• Ability to command the attention and lead higher level managers and senior subject matter experts.
• Proactive and able to drive the document to its conclusion.
• Enjoy working closely with project teams, particularly Clinical Operations, Regulatory Affairs, and clinical and nonclinical development teams.