Responsibilities Include
Maintains consistent high quality and efficiency in the generation of technical documentation to support regulatory filings
Assists with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and orphan drug applications for cell and gene therapy programs
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.
Works with technical 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
Manages document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones, and document deliverables.
Ensures documents are finalized for submission including publishing readiness, quality checks and finalization of all supporting literature
Trains on company document management systems, authors and/or reviews departmental (clinical and regulatory) SOPs as needed
Performs other activities as assigned