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Senior Medical Writer - 1 Year Contract

Icon Plc
ICON PLC
3-5 years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Senior Medical Writer (1-Year Contract)
Location: Remote
Company: ICON plc

Role Overview

ICON is seeking a Senior Medical Writer to join the world’s largest and most comprehensive clinical research organization. You will support a Top-5 pharmaceutical company in delivering regulatory and submission documents across multiple therapeutic areas, from Phase 1 to Phase 3. This is a 1-year fixed-term contract.

Key Responsibilities

  • Independently produce clinical and regulatory documents, such as clinical summary documents, briefing books, response documents, and PIPs.
  • Analyze and interpret data to determine the best approach to document preparation, applying lean writing strategies.
  • Act as the primary contact for the study team regarding document preparation and timelines.
  • Facilitate document reviews and ensure that all documents are submission-ready and approved.
  • Collaborate with QC personnel and publishing specialists for document preparation.

Qualifications & Experience

  • Education: Minimum Bachelor’s degree (Master’s preferred).
  • Experience: 3-5 years in medical writing or relevant pharmaceutical experience with a strong understanding of scientific and regulatory aspects.
  • Skills:
    • Strong writing skills, with the ability to convert scientific data into clear, structured messages.
    • Proficient in independently writing various clinical/regulatory documents.
    • Experience in leading document creation, coordinating authorship, and facilitating reviews to ensure submission-readiness.

What ICON Offers

  • Stable employment with ICON while being embedded with the client.
  • Opportunity to work on top-tier projects with a leading pharmaceutical company.

Interested? Apply now to join ICON and contribute to the future of clinical research.