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

**About the Position** ---------------------- 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 Include** ---------------------------- * 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 **Required Qualifications** --------------------------- * Bachelors or masters degree in biological sciences; with 6 years’ experience or Ph.D. and 2 years’ experience in a technical writing capacity * Familiarity with the key requirements for regulatory submissions in ICH regions as stipulated in applicable regulations and guidelines for pharmaceuticals/biologics * Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IMPD, INDs, MAAs, NDAs, and BLAs, is preferred * Ability to critically analyze, synthesize, and present complex information in well\-constructed documents * Working knowledge of drug/biologics de