Manager, Medical Writer and Quality Control

About the role

Reporting to the Senior Director, Clinical Medical Writing, the Manager, Medical Writer and 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 Medical/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

• Bachelor’s or master’s 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 development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
• Confidence to present to management, peers, and scientific or business collaborators
• Ability to support multiple projects and to prioritize work independently
• Ability to comply with company and/or industry style guides and templates
• Ability to guide and train others in the writing of technical documentation
• Fluent with written and spoken English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy
• Advanced MS Skills in Word, Excel, and Adobe Pro
• Strong team orientation and passion for continuous self-development
• Experience in the biotech industry or in a startup industrial setting is preferred