Senior Medical Writer
About The Position
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Description of Role The Senior Medical Writer will be responsible for authoring and managing clinical regulatory documents in support of the company’s clinical development program and objectives. Reporting to the Director, Medical Writing Operations, the Senior Medical Writer will efficiently prepare high-quality, consistent, and accurate deliverables across the company’s development portfolio.
Requirements
- Advanced degree; PhD, PharmD or Master's degree in a scientific/clinical discipline or English.
- 4+ years of medical writing or relevant pharmaceutical industry experience, including at least 2 years in sponsor-level clinical/regulatory medical writing.
- Strong organizational, communication, and influencing skills; ability to prioritize, multitask, and deliver high-quality documents under tight timelines.
- Flexibility and comfortability with evolving priorities and targets.
- Understanding of drug development, biostatistics, and medical terminology; basic understanding of scientific methodology as applied to drug development.
- Knowledge of global clinical trials and regulatory submission requirements (FDA, EMA, PMDA), including ICH, GCP, CTD/eCTD, and EU privacy/redaction regulations.
- Proficiency in Microsoft Word (advanced features) and familiarity with document management and collaborative authoring platforms (e.g., Veeva Vault, Please Review).
- Ability to work independently and collaboratively in a dynamic, fast-paced, cross-functional environment.
- Highly accurate, detail-oriented, and professional, with excellent interpersonal skills and a calm, diplomatic approach to challenges.
Nice To Haves
- Previous neuroscience experience is strongly preferred.
Responsibilities
- Author and provide support for medical writing content, including but not limited to study level documents (clinical protocols and amendments, Investigator Brochures, clinical study reports), agency requests for information, IND/CTA submission documents, NDA/MAA clinical modules and summary documents, and other writing as necessary.
- Collaborate closely with relevant functions, including Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, and Project Management teams.
- Partner with internal and external writers, as necessary, in support of document completion.
- Oversee document preparation from start to finish, including kick-off activities and planning, drafting, managing review cycles, incorporating feedback and revisions, addressing quality control and quality assurance findings, and providing a final version within document timelines.
- Ensure clarity, consistency, and proper formatting of clinical documents across programs.
- Maintain compliance with GCP, ICH, eCTD, and company guidelines.
- Interpret complex clinical data and information.
- Demonstrate strategic thinking and review capabilities.
- Contribute to the development and improvement of SOPs, templates, and document standards.
Benefits
- In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa’s long-term success.
- Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
