Sr. Manager, Medical Writing

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.

• Author and manage the development of clinical and regulatory documents including protocols, amendments, clinical study reports (CSRs), investigator brochures (IBs), and at times 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.

• 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.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work. 

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