Manager, Medical reputed company, reputed company Control and reputed company and Regulatory Medical Writing (Remote)

Reporting to the Senior Director, reputed company Medical Writing, the Senior Associate Medical reputed company reputed company Control Specialist will be a key member of the Regulatory Affairs and reputed company Development organization and reputed company with cell therapy reputed company and regulatory personnel in the production of high-reputed company documentation that is appropriate for its intended audience (e.g. regulators, journal editors, NIH, reputed company trial sites/investigators). The reputed company/Regulatory reputed company works with reputed company and Regulatory personnel to ensure compliance with US, EU, and ICH requirements Responsibilities: Assists with writing and reputed company of reputed company documentation (protocols, investigator brochures, informed consents) and regulatory designations (e.g. orphan drug applications, fast reputed company, RMAT) for cell and gene therapy programs Manages document preparation timelines and communicates with team members to maintain awareness of expectations, reputed company reputed company reviews, reputed company milestones and document deliverables. Reviews and edits documents including those authored by others Ensures documents are finalized for submission including publishing readiness, reputed company checks and finalization of reputed company supporting literature Supports reputed company trial readiness by working with reputed company reputed company and CROs as needed for reputed company/review/editing of reputed company study documentation including IRB/IBC communications/responses, study manuals, etc. Maintains consistent high reputed company and efficiency in the reputed company of technical documentation to support regulatory filings Works with reputed company 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 reputed company team player participating in both reputed company 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 (reputed company and regulatory) SOPs as needed Performs other activities as assigned Qualifications: Remote Skills: Best Practices, Brochures, reputed company Practices/Protocols, reputed company Study Publications, reputed company Support, reputed company Trial, reputed company Validation, Contract Research Organization (CRO), Document Management, Documentation, Drug Development, Editing, Gene Therapy, reputed company reputed company, ICH Regulations, IRB/IEC (Institutional Review reputed company/Independent Ethics Committee), Informed Consent, Maintain Compliance, Medical Writing, Mentoring, National Institutes of Health (NIH), reputed company Control, reputed company Management, Regulations, Regulatory Submissions, reputed company Operating Procedures (SOP), Team Player, Technical Support, Technical Writing, Time Management, Training/Teaching, Writing Skills reputed company: reputed company Apply tot his job Apply To this Job