Job Description
Medical Writer/Senior Medical Writer Why Work With Us? At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day.
Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients.
Learn more:
Position Summary: We are seeking a highly skilled
Medical Writer to support our clinical pipeline and upcoming BLA submission by developing high-quality clinical and regulatory documents. The ideal candidate will bring expertise in oncology, strong scientific and regulatory writing skills, and experience supporting key submissions such as protocols, manuscripts, and Biologics License Applications (BLAs). This role is critical to our mission and will work cross-functionally with Clinical, Regulatory, R&D, and Biostatistics teams to drive impactful communications across development programs.
Key Responsibilities: - Contribute to the preparation, development, and finalization of clinical and regulatory documents related to oncology programs, including:
- Clinical study protocols and protocol amendments
- Investigator brochures (IBs)
- Clinical study reports (CSRs)
- BLA components, especially Modules 2.5 (Clinical Overview), 2.7 (Clinical Summary), and Module 5
- Peer-reviewed manuscripts, abstracts, and scientific presentations
- Work closely with cross-functional teams to hensure the scientific accuracy and consistency of messaging across documents.
- Translate complex oncology clinical and scientific data into clear, concise, and compelling narratives for regulatory agencies and scientific audiences.
- Drive document development timelines, proactively identify risks or bottlenecks, and ensure timely completion of deliverables.
- Ensure all documents comply with applicable regulatory guidelines (ICH, FDA, EMA), company SOPs, and internal quality standards.
- Contribute to the development and maintenance of medical writing templates, processes, and SOPs.
Qualifications: - Degree in life sciences; Advanced degree a plus.
- 7+ years of medical writing experience in the pharmaceutical, biotech, or CRO industry, with significant experience in oncology.
- Strong knowledge of oncology clinical trial design, endpoints, and evolving regulatory expectations.
- Exceptional writing, editing, and project management skills; able to synthesize complex data into accurate and persuasive scientific content.
- Comfortable working independently and within cross-functional teams in a fast-paced, deadline-driven environment.
- Familiarity with document management systems.
Job Tags
Full time,