Senior Manager, Medical Writing (Psychiatry/Neurology)

Job Overview

We are currently seeking an accomplished and motivated individual for the role of Senior Manager, Medical Writing (Psychiatry/Neurology).

Job Duties and Responsibilities

  • Develop strategic medical writing plans that align with program and project objectives, adhering to applicable guidelines (ICH, CFR, etc.) and SMPA templates and SOPs.
  • Assess resource requirements to achieve regulatory submission document milestones and timelines as outlined in medical writing plans.
  • Provide mentorship and guidance to Medical Writing staff (internal/external) to ensure document development aligns with medical writing plans.
  • Perform senior-level review of regulatory submission documents prepared by Medical Writing staff (internal/external).
  • Author and review documents for regulatory submissions (protocols, investigator brochures, clinical study reports, IND and NDA summary documents) in support of CNS clinical development programs.
  • Collaborate with subject matter experts to shape document strategies and messages for accurate and concise presentation.

Education and Experience

  • Minimum of Bachelor’s degree required
  • Minimum 8 years of industry experience in biotech/pharma industry  
  • Extensive medical writing experience; document writing and review across the clinical development life-cycle from IND to NDA and beyond.
  • Experience as a medical writing representative on cross-functional teams.



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