This position is no longer available
United Kingdom Remote (Country)

ICON plc was looking for a Senior/Principal Medical Writer

Join a globally recognized organization as a Senior or Principal Medical Writer on a 12-month fixed-term, fully remote contract. This role supports a leading pharmaceutical client with the end-to-end development of critical clinical documentation, requiring strong scientific acumen, regulatory knowledge, and leadership in medical writing processes.

Key Responsibilities

  • Author study-level documents independently, ranging from protocols and protocol outlines to clinical study reports and investigator brochures
  • Prepare informed consent forms and lay summaries of trial results for public disclosure
  • Support senior colleagues in developing complex submission documents and integrated reports
  • Interpret clinical data, summarize findings, and ensure scientific accuracy across deliverables
  • Lead discussions around medical writing strategy, timelines, and document scope
  • Coordinate with stakeholders to align on objectives and drive decisions on trial-specific writing needs
  • Represent medical writing in cross-functional teams, including clinical, regulatory, and publication planning groups
  • Manage timelines and ensure compliance with internal procedures and external guidelines

Qualifications

  • Proven experience writing regulatory documents such as protocols, CSRs, and IBs within pharma or CRO settings
  • Direct involvement in submission processes or components of regulatory submissions
  • Ability to manage medical writing projects independently, including planning and execution
  • Strong interpersonal skills with a track record of building collaborative relationships
  • Skilled at facilitating decision-making and resolving challenges through clear communication
  • Comfortable working autonomously, consulting SOPs and guidance materials before escalating issues
  • Active engagement with stakeholders to define goals, strategy, and deliverable scope

Benefits

Eligible employees receive comprehensive support including generous annual leave, flexible benefits tailored to local countries, health insurance options, retirement planning, and access to a global Employee Assistance Programme via TELUS Health. Additional offerings may include life assurance, childcare support, gym discounts, bike purchase schemes, subsidized travel, and health assessments—depending on location.

Work Environment

This position is fully remote, available to candidates based in the UK or Europe. The organization fosters an inclusive, high-performance culture grounded in diversity, equity, and accessibility. All qualified applicants are considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Required Skills
Regulatory writingProtocol developmentClinical Study Reports (CSRs)Investigator Brochures (IBs)Submission experienceProject managementStakeholder communicationTeam collaboration Regulatory WritingClinical Study Reports (CSRs)Investigational Brochures (IBs)ProtocolsSubmission ExperienceProject ManagementStakeholder EngagementPharmaceutical DocumentationCRO ExperienceProactive Collaboration
About company
ICON plc
A world-leading healthcare intelligence and clinical research organization shaping the future of clinical development.
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Posted 4 months ago