Senior Medical Writer

September 22, 2022
North Carolina
Job Type
Work Setting


Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of forward-thinking individuals achieve this through an unwavering commitment to support accessibility to medicine, providing new therapeutic solutions, and collaborating with governments and payers to ensure that people who need medicines have access to them. Our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.​

Impact our team as a Medical Writer!

Our Medical Writing Department strives to be the premier regulatory documentation organization in the bio-pharmaceutical industry. Our Medical Writers are integral to helping bring medical breakthroughs to the world. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, and innovative medicine. We rely on expert skills and inventiveness that contribute to solutions to the most pressing health challenges.

The Senior Medical Writer is responsible for development of medical writing deliverables that support the clinical regulatory writing portfolio and works with some guidance and oversight to achieve goals.

In this role the Senior Medical Writer

  • Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation
  • Applies knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects
  • Represents medical writing in cross-functional teams
  • Demonstrates competence in writing, editing, and reviewing clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents per company and other guidelines
  • Interprets data and applies knowledge of regulatory/compliance/scientific requirements to document preparation
  • Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings
  • Solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members
  • May participate in orientation and coaching of junior team members or contractor writers
  • Participates in or leads initiatives to improve medical writing processes and standards

Education Minimum Requirement

  • Bachelor's Degree or higher in the Life Sciences

Required Experience and Skills

  • Bachelor’s degree with 5+ years; MS with 4+ years; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with 3+ years of relevant career experience
  • Ability to prepare, with minimal supervision, a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations, and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
  • Demonstrated participation in medical writing, document, and project teams
  • Technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., Google Docs, SharePoint). Familiarity with concepts of structured content management preferred
  • Demonstrated excellent presentation, writing, and project management skills

Preferred Experience and Skills

  • Experience in oncology regulatory writing
  • Advanced degree in Life Science
  • Familiarity with concepts of structured content management

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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