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10 Dec. 6, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences/ phD 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

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Principal Medical Writer
Location: Home-Office Based
Company: ICON plc

Role Overview

ICON is seeking a highly skilled Principal Medical Writer to join the world's largest clinical research organization. This role supports a Top-5 biotech company in the autoimmune disease space, offering the opportunity to deliver regulatory and submission documents that reduce time to market for their antibody pipeline. You will be stably employed with ICON while being fully embedded with the client, benefiting from continued learning opportunities and long-term career growth.

Key Responsibilities

  • Medical Writing Excellence:

    • Deliver a wide range of clinical, regulatory, and submission documents such as clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, eCTD modules, and more.
    • Ensure documents are well-organized, accurate, and aligned with target audiences.
    • Provide guidance on content and processes to clinical teams.
    • Uphold company SOPs and regulatory requirements.
  • Functional Leadership:

    • Lead cross-functional teams and advise on best-in-class medical writing processes.
    • Ensure consistency across documentation using company style guides.
    • Provide recommendations for process improvements to maintain high-quality regulatory document delivery.
    • Represent the medical writing function at internal meetings and during audits.

Qualifications & Experience

  • Education:
    • Master’s degree in a scientific, medical, or clinical discipline (PhD preferred).
  • Experience:
    • Minimum 6 years in pharmaceutical/biotech medical writing.
    • Expertise in FDA and ICH guidelines for clinical reporting and eCTD submission.
    • Understanding of key phases of drug development from protocol development through submission.
    • Experience in electronic publishing is preferred.

Skills:

  • Excellent communication and collaboration skills.
  • Innovative mindset and proactive in suggesting process improvements.
  • Ability to proofread and ensure compliance with regulatory guidelines.
  • Ability to drive document consistency across therapeutic indications.

Benefits

  • Competitive base pay, variable pay, and recognition programs.
  • Comprehensive employee benefits and wellbeing initiatives tailored to support you and your family.
  • Opportunities for career development and professional growth within ICON.

Why ICON?
ICON is committed to supporting employee development through continuous learning and professional challenges. Join a diverse and inclusive organization, providing equal opportunities for all.

Interested? Apply now to become a key medical writer for a leading biotech company while continuing to grow with ICON.