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’s will efficiently prepare high-quality, consistent, and accurate deliverables across the company’s development portfolio.
Key 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.
Qualifications
- PhD or advanced degree in a scientific or clinical discipline.
- 4+ years of medical writing or relevant pharmaceutical industry experience, including at least 2 years in sponsor-level clinical/regulatory medical writing.
- Previous neuroscience experience is strongly preferred.
- 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.
Compensation
The annual base salary range for this position is $135,000.00 to $180,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.
In addition to base pay, this role is eligible for a discretionary annual bonus. 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.
Work Location
The Senior Medical Writer role is based in the US, with occasional travel.
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
