Senior Medical Writer

Candel Therapeutics•Needham, MA

2d•$150 - $180•Remote

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)
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

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