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Senior Medical Writer

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Job Description:

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.

Job Responsibility:

  • Deliver high quality relevant Clinical Pharmacology & Pharmacometrics (CPP) documents (e.g. population PK/PD data transfer plans, population PK/PD analysis plans and population PK/PD reports), as well as CSRs, protocols, and other documents, within the required regulatory system per global aligned procedures of the client
  • Write clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents
  • Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers
  • Provide scientific and medical writing consultancy to project teams, as requested
  • Services rendered will adhere to applicable client’s SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
  • Ensure clear communication with clinical pharmacology & pharmacometric leaders and other team members
  • Ensure deliverables are inspection ready and compliant with relevant requirements
  • Maintain the central planning of population PK/PD document writing and QC deliverables

Requirements:

  • Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
  • Minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry
  • Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses
  • Excellent writing, editing, and proofreading skills
  • Ability to communicate scientific concepts to diverse audiences
  • Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications
  • Experience in interacting with regulatory agencies during the review and approval process
  • Demonstrated ability to work effectively in a fast-paced, deadline-driven environment
  • Ability to manage multiple projects simultaneously and prioritize tasks based on project timelines and deliverables
  • Excellent interpersonal and communication skills
  • Ability to collaborate effectively with cross-functional teams
  • Ability to build relationships with key stakeholders
  • Ability to influence decision-making processes
What we offer:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Additional Information:

Job Posted:
February 17, 2026

Work Type:
Remote work
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