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Medasource Logo Medasource · IT - Software Development

Lead Medical Writer

United States, Dublin 80.00 - 95.00 USD / Hour · Job Posted May 31, 2026
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Job Description

Our client is a global healthcare services and products company providing pharmaceuticals, medical products, and supply chain solutions to hospitals, pharmacies, and healthcare providers. The organization plays a critical role in helping healthcare systems improve efficiency, reduce costs, and enhance patient care through integrated distribution and data-driven solutions. As a Lead Medical Writer on a 2-month remote contract, you will autonomously author and review a range of clinical regulatory documents, including CTD Module II summaries, Clinical Overviews, Clinical Study Reports (CSRs), and responses to health authority queries. You will contribute scientifically and strategically to submission teams, plan data analyses, review statistical analysis plans, and collaborate with cross-functional stakeholders such as Clinical Sciences, Clinical Pharmacology, Biometry, Drug Safety, Clinical Operations, CMC, and Regulatory Affairs. This role requires advanced medical writing skills, deep knowledge of regulatory requirements, the ability to mentor junior writers, and strong interpersonal and presentation abilities. Candidates must be available to work in the Eastern Standard Time zone.

Job Responsibility

  • Autonomously write and review clinical regulatory documents, including CTD Module II summaries, Clinical Overviews, Clinical Study Reports (CSRs), and other regulatory submissions such as responses to health authority questions, briefing books, 120-day safety updates, pediatric investigational plans, and investigator brochures
  • Contribute scientifically and strategically to submission teams at the project and/or study team level, providing input on pooling strategy, content expertise, and guidance on regulatory requirements
  • Plan and review data analyses and presentations for CSRs
  • review statistical analysis plans and related documents
  • Collaborate effectively with cross-functional stakeholders, including Clinical Sciences, Clinical Pharmacology, Biometry, Drug Safety, Clinical Operations, CMC, and Regulatory Affairs
  • Work with in-house Documentation Specialists to produce high-quality final documents and ensure timely delivery
  • Mentor and develop junior medical writers, providing guidance and support as needed
  • Demonstrate advanced medical writing skills and maintain up-to-date knowledge of regulatory document requirements and guidelines
  • Work independently and as part of a team, managing multiple priorities and meeting challenging deadlines
  • Exhibit excellent interpersonal and presentation skills in all interactions
  • Maintain advanced proficiency in English for all written and verbal communications

Requirements

  • Advanced degree in life sciences (PhD, PharmD, MD, or MS preferred)
  • 5+ years of regulatory/medical writing experience in the pharmaceutical industry across several therapeutic areas
  • Proven ability to autonomously write and review clinical regulatory documents (e.g., CTD Module II summaries, CSRs, Clinical Overviews, Investigator brochures, and other regulatory submissions)
  • Strong knowledge of regulatory document requirements and guidelines
  • Experience contributing scientifically and strategically to submission teams
  • Ability to plan data analyses and review statistical analysis plans for CSRs
  • Excellent collaboration skills with cross-functional stakeholders
  • Well-developed medical writing skills with attention to quality and deadlines
  • Ability to mentor and develop junior medical writers
  • Ability to work independently and as part of a team
  • Strong interpersonal and presentation skills
  • Advanced level of English proficiency
  • Ability to work under pressure and meet challenging deadlines
  • Remote work capability with availability in Eastern Standard Time (EST)

What we offer

  • Medical coverage
  • Dental coverage
  • Vision coverage
  • Health Savings Account
  • Dependent Care FSA
  • Supplemental coverage
  • 401k plan with company match
  • Paid time off
  • Sick time
  • Paid company holidays
  • Employee Assistance Program (EAP) with virtual counseling, financial services, legal services, life coaching
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