Associate Director, Regulatory Strategic Writing
About The Position
We are seeking an experienced Associate Director, Regulatory Strategic Writing to lead, plan, author, and manage high-quality clinical and regulatory documents for Candel’s oncology programs. The role will be responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections of INDs, BLAs, and MAAs. This role will also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Strategic Writing must possess advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics). This role is remote within the U.S., with preference for candidates in Eastern or Central time zones.
Requirements
- 7+ years’ medical writing in pharma/biotech/CRO with substantial oncology experience preferred
- A bachelor’s degree is required. A relevant advanced degree (e.g. MS, Pharm D, PhD, MD) is preferred and may substitute for years of experience. American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing Experience in Regulatory Affairs either via industry or education; knowledgeable of US and international regulations, requirements and guidance associated with clinical research and drug development. Ability to assimilate and interpret and translate information for appropriate audiences.
- Working knowledge of current electronic document management systems and information technology; knowledge of and experience with Common Technical Document content templates. Excellent working knowledge of software programs in a Windows environment.
- Prior authorship experience of BLA clinical modules (2.5, 2.7, relevant 5), CSRs, and IBs
- Contributions to protocols/amendments, SAP-aligned tables/appendices, briefing packages, and health-authority responses
- Strong knowledge of ICH/FDA/EMA; oncology trial design, endpoints, and evolving regulatory expectations
- Ability to interpret clinical and statistical results and craft clear, compliant regulatory narratives
- Exceptional writing, editing, and project management; effective independent and cross-functional execution in fast, deadline-driven settings
- Ownership of document strategy, outlines and timelines, version control, and end-to-end review to audit-ready quality
- Direct experience with submission and inspection readiness, including quality control, data traceability, and comment reconciliation
- Participation in major submissions (BLA/NDA/MAA) through filing and review including assisting with responses to Agency queries.
- Proficiency with document and workflow systems (e.g., Veeva, eTMF, CTMS, electronic review tools)
- Proven collaboration with Clinical, Biostatistics, Regulatory, Safety, and CMC; consistent milestone and risk tracking with timely issue resolution
- Ability to work core Eastern or Central U.S. hours (remote, U.S.-based)
- Applicants must be legally authorized to work in the United States at the time of hire and throughout employment. We are unable to provide, assume, or sponsor work visas or employment authorization for this role now or in the future.
Responsibilities
- Write critical, complex clinical and regulatory documents (eg, pivotal Phase 3 CSRs, BLA/MAA submission documents, and briefing books) with minimal input from functional area experts; Ensure key messages are clear and consistent within and across documents
- Critically review documents produced by other writers for scientific content and alignment with company position, clarity, accuracy, and consistency
- Contribute strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data, and support the authoring of documents for filings or responding to health authority requests; Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documents
- Assess resource requirements, proactively identify issues and solutions, and contribute to the development of timelines and processes Document strategy and project management:
- Develop document strategies, outlines, and timelines
- Manage version control and drive document review cycles to audit-ready completion
- Coordinate input from Clinical, Biostatistics, Regulatory, Safety, and CMC functions to ensure accuracy, consistency, and timely deliveryData interpretation and narrative development:
- Translate complex clinical and statistical results into clear, consistent regulatory narratives aligned with labeling and submission objectives
- Ensure compliance with ICH guidelines, FDA/EMA guidance, company SOPs, and style conventions
- Contribute to template and process improvements
- Support inspection and submission readiness, including document quality checks, traceability to source data, and comment reconciliation
- Track milestones and risks, escalate issues proactively, and drive resolution to maintain delivery commitments
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
