Job description
Senior Manager, Medical Writing
Job Description
The Senior Manager, Medical Writing is a key member of the Clinical Development organization, responsible for independently authoring, managing, and delivering high-quality clinical documents across all phases of development. In addition to hands-on writing, this role provides strategic input into clinical development and regulatory submissions, leads process improvements within Medical Writing, and oversees external writing resources.
Responsibilities
- Author and manage the development of clinical and regulatory documents including protocols, amendments, clinical study reports (CSRs), investigator brochures (IBs), and clinical modules of regulatory submissions.
- Collaborate cross-functionally with Biostatistics, Clinical Operations, Clinical Research, Regulatory Affairs, and other functions to ensure alignment of messaging and data accuracy.
- Manage and oversee work outsourced to contract medical writers and CRO partners, ensuring high-quality deliverables.
- Provide project management oversight for writing deliverables across multiple programs, ensuring timelines and quality expectations are met.
- Drive process improvements, including developing and maintaining document templates, style guides, and best practices.
- Serve as a key partner in clinical development strategy planning, offering insight into document planning, messaging, and content structure.
Qualifications
- Advanced degree (MS, MPH, PhD, PharmD) in life sciences preferred.
- 5+ years of relevant medical writing experience in clinical research, including protocol and CSR writing.
- Strong understanding of ICH guidelines, GCP, and global regulatory requirements.
- Exposure to neuroscience or psychiatry areas is preferred, but not required.
- Excellent written and verbal communication skills, with proven ability to influence and collaborate across diverse teams.
- Experience with document management systems (e.g., Veeva Vault).
- Proficiency in the Microsoft Office Suite.