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Job OverviewWe 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.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
