Senior Manager, Technical Writer, Regulatory Affairs (Remote)

Senior Manager, Technical Writer, Regulatory Affairs (Remote)

Philadelphia, PA

About the Position

Reporting to the Associate Director, Medical and Regulatory Writing, the Senior Manager, Regulatory Technical Writer will be a key member of the Clinical Development organization and interface with cell therapy clinical, nonclinical, and manufacturing research personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators). The technical 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 orphan drug applications 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.

• 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 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

• 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 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.

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