Senior Medical Writer
Listed on 2026-02-16
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Healthcare
Healthcare Administration
Cell Centric is a clinical-stage biopharmaceutical company, science driven and patient focused. Our drug, inobrodib is a first-in-class p300/CBP inhibitor that is being developed for the treatment of multiple myeloma and other specific cancers. Our aim is to develop inobrodib as quickly and as effectively as possible for the benefit of patients.
Position SummaryThe Senior Medical Writer is responsible for the planning, development, and delivery of high-quality clinical, regulatory, and other technical documents across the product lifecycle. This role provides strategic and operational leadership for key writing deliverables, manages contractors, partners cross-functionally (Clinical, Regulatory, Biostats, Safety, CMC), and ensures documents meet global regulatory requirements, timelines, and company standards. This individual will contribute to the success of the team and organization by delivering on role-specific responsibilities while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and Enablement.
Key Responsibilities- Lead authoring of complex, high-impact documents (e.g., CSRs, protocols, IBs, CTDs/Modules, briefing books).
- Drive consistent scientific messaging across clinical, regulatory, and other deliverables.
- Serve as primary writing representative on cross-functional program and study teams.
- Plan, outline, draft, and finalize clinical/regulatory documents, ensuring accuracy, clarity, and compliance.
- Integrate and interpret data from clinical, statistical, and safety sources into clear, defensible narratives.
- Coordinate review cycles, resolve comments, and ensure alignment across functions.
- Manage outsourced writing projects and vendors (scope, timelines, quality, budget).
- Collaborate effectively with colleagues, sharing knowledge and supporting team goals.
- Contribute to problem-solving and decision-making processes with an objective, data-driven approach.
- Communicate clearly and proactively with stakeholders to ensure alignment.
- Support team members through constructive feedback, mentorship, and collaboration.
- Education:
Bachelor’s degree + significant relevant experience considered. Advanced degree preferred. - Experience:
Typically 6-8+ years of medical/technical writing experience in biotech/pharma/CRO, including leadership on major regulatory and clinical documents. - Experience in oncology preferred
- Strong working knowledge of ICH guidelines, global regulatory requirements, and document standards.
- Experience supporting IND/CTA, BLA/NDA/MAA submissions and health authority responses.
- Experience mentoring writers and/or managing vendors and outsourced deliverables.
- Excellent project management skills with a track record of meeting aggressive timelines.
- Superior written and verbal communication; ability to translate complex data into clear narratives.
- Strong interpersonal and communication skills, with the ability to adapt to different audiences.
- Proven ability to build trust and credibility through integrity, openness, and respect.
- Demonstrated accountability in delivering results and meeting commitments.
- Analytical mindset with the ability to use facts and data to guide decisions.
- Ability to work both independently and collaboratively within a team.
- Trust and Respect:
Act with integrity, honesty, and openness to build strong, credible relationships. - Communication and Feedback:
Share information clearly, listen actively, and engage in a culture of constructive feedback. - Accountability and Reliability:
Take ownership for performance, be dependable, and support others to achieve collective goals. - Objectivity:
Align on common objectives and use facts and data to reach fair, effective decisions. - Team Balance and Enablement:
Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.
At Cell Centric, we believe success is built on great teams. By embodying these working behaviors, every member contributes to a high-performing, supportive, and inclusive culture where individuals and the business thrive together.
How to ApplyPlease send your CV and covering letter to
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