ICON plc

Senior/Principal Medical Writer

ICON plc

contract

Posted on:

Location Type: Remote

Location: Denmark

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Job Level

Senior

About the role

  • Independently author most study-level documents at simple to complex levels, for example: Protocol, protocol outlines, Subject Information/Informed Consent, Clinical study reports (CSRs), Lay summaries of clinical trial results, Investigator brochures (IBs).
  • Provide support to more experienced writers with the preparation of submission and other complex clinical documents.
  • Capable of interpreting and summarizing data.
  • Drive discussions, ensure decisions are taken and incorporate project strategies in documents.
  • Lead meetings and drive decisions concerning project/trial-specific medical writing issues.
  • Responsible for all medical writing aspects of task finalization including stakeholder alignment, coordination, and adherence to timelines.

Requirements

  • Experienced in writing regulatory documents for pharma or CRO, such as protocols, CSRs, IBs
  • Submission experience (or components of submission)
  • Project Management of own MW projects
  • Highly pro-active team player.
  • Skilled in building and maintaining good working relationships with stakeholders and colleagues.
  • Strong engagement with stakeholders to understand and align on the purpose/strategy, timing, and scope of MW tasks.
  • Strong facilitation, communication and problem-solving skills to effectively manage interactions with all stakeholders and drive decision making.
  • Can work independently and demonstrate resourcefulness.
Benefits
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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
medical writingregulatory documentsprotocolsclinical study reportsinvestigator brochuresdata interpretationsubmission experienceproject management
Soft Skills
team playerrelationship buildingstakeholder engagementcommunicationproblem-solvingfacilitationresourcefulness