Manager, Medical Writer, Quality Control and Clinical and Regulatory Medical Writing (Remote)

Reporting to the Senior Director, Clinical Medical Writing, the Senior Associate Medical Writer Quality Control Specialist will be a key member of the Regulatory Affairs and Clinical Development organization and interface with cell therapy clinical and regulatory personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, journal editors, NIH, clinical trial sites/investigators). The Medica/Regulatory writer works with Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements Responsibilities: Assists with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and regulatory designations (e.g. orphan drug applications, fast track, RMAT) for cell and gene therapy programs Manages document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables. Reviews and edits documents including those authored by others Ensures documents are finalized for submission including publishing readiness, quality checks and finalization of all supporting literature Supports clinical trial readiness by working with clinical operations and CROs as needed for generation/review/editing of clinical study documentation including IRB/IBC communications/responses, study manuals, etc. Maintains consistent high quality and efficiency in the generation of technical documentation to support regulatory filings Works with clinical and translational teams to convert technical study data and results into reports in support of regulatory submissions. Provides training and mentoring to subject matter experts on technical writing skills and best practices Reviews and edits documents including those authored by others both internally and externally Is a collaborative team player participating in both internal and external project team meetings as needed, and offers proactive solutions and advice to team members Trains on company document management systems, authors and/or reviews departmental (clinical and regulatory) SOPs as needed Performs other activities as assigned Qualifications: