Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Senior Medical Writer

Boston, MA · Senior · Full-time

Sponsorship not specified$150k-$190kDetected 6 days ago
GCPProject ManagementClinical TrialsFDA RegulatoryPharmacovigilanceCommunicationMicrosoft OfficeBiostatisticsRegulatory Affairs

About the role

  • 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.
  • Work Location The Senior Medical Writer role is based in the US, with occasional travel.
  • We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Responsibilities

  • 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.
  • Contribute to the development and improvement of SOPs, templates, and document standards.

Requirements

  • 4+ years of medical writing or relevant pharmaceutical industry experience, including at least 2 years in sponsor-level clinical/regulatory medical writing.
  • ability to prioritize, multitask, and deliver high-quality documents under tight timelines.
  • Understanding of drug development, biostatistics, and medical terminology
  • Highly accurate, detail-oriented, and professional, with excellent interpersonal skills and a calm, diplomatic approach to challenges.

Nice to have

  • Interpret complex clinical data and information.
  • Demonstrate strategic thinking and review capabilities.
  • PhD or advanced degree in a scientific or clinical discipline.
  • Previous neuroscience experience is strongly preferred.
  • Strong organizational, communication, and influencing skills
  • Flexibility and comfortability with evolving priorities and targets.
  • 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.

Compensation

  • The annual base salary range for this position is $150,000.00 to $190,000.00. 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.

Benefits

  • 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.
  • The Senior Medical Writer role is based in the US, with occasional travel.

Company info

  • 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.

Visa & Work Authorization

  • 4+ years of medical writing or relevant pharmaceutical industry experience, including at least 2 years in sponsor-level clinical/regulatory medical writing
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