Principal Medical Writer
About The Position
We are seeking an experienced Senior Medical Writer to lead, plan, author, and manage high-quality clinical and regulatory documents for Candel’s oncology programs. The role focuses on authorship of BLA components, Clinical Study Reports (CSRs), and Investigator’s Brochures (IBs). This position requires hands-on regulatory writing expertise aligned with ICH, FDA, and EMA expectations, strong cross-functional collaboration, and disciplined project management to meet key submission timelines. 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
- Bachelor’s degree in life science (advanced degree preferred)
- Authorship 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)
Responsibilities
- Regulatory authorship and content development:
- Serve as an author for BLA clinical modules, including Module 2.5 Clinical Overview, Module 2.7 Clinical Summary, and relevant Module 5 clinical study content
- Author and update Clinical Study Reports, Investigator’s Brochures, and SOPs.
- Contribute to protocols, protocol amendments, SAP-aligned data displays and appendices, clinical sections of briefing packages, and responses to health-authority queries
- Document strategy and project management:
- Develop document strategies, outlines, and timelinea
- Manage version control and drive document review cycles to audit-ready completion
- Cross-functional collaboration:
- Coordinate input from Clinical, Biostatistics, Regulatory, Safety, and CMC functions to ensure accuracy, consistency, and timely delivery
- Data interpretation and narrative development:
- Translate complex clinical and statistical results into clear, consistent regulatory narratives aligned with labeling and submission objectives
- Standards, compliance, and process improvement:
- Ensure compliance with ICH guidelines, FDA/EMA guidance, company SOPs, and style conventions
- Contribute to template and process improvements
- Submission and inspection readiness:
- Support inspection and submission readiness, including document quality checks, traceability to source data, and comment reconciliation
- Milestone, risk, and issue management:
- 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
Number of Employees
11-50 employees
