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Senior Manager, Technical Writer, Regulatory Affairs Remote: Tell Me More
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- clinical trials with CAB201 (investigational CD19-CAR T cell therapy) in
- Senior Manager, Technical Writer, Regulatory Affairs (Remote)
- Reporting to the Associate Director, Medical and Regulatory Writing, the Senior Manager, Regulatory Technical Writer will be a key member of the Clinical Development organization and interface with cell therapy clinical, nonclinical, and manufacturing research personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators).
- The technical writer works with Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements.
- Assists with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and orphan drug applications for cell and gene therapy programs
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