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    Principal Medical Writer

    Icon Plc
    5-6 years
    Not Disclosed
    Spain
    10 Dec. 6, 2024
    Job Description
    Job Type: Full Time 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

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

    Role Overview

    ICON is seeking a Principal Medical Writer to join the world’s largest and most comprehensive clinical research organization. This role will involve leading the development and implementation of content strategies for clinical submission documents, particularly in the oncology field. You will be pivotal in driving regulatory submissions, ensuring high-quality documents are delivered on the critical path to drug approval.

    Key Responsibilities

    • Medical Writing Leadership:

      • Act as the expert for assigned drug projects, leading the planning, development, and implementation of content strategies for clinical submission documents.
      • Design clinical submission documents aligned with the Clinical Development Plan, ensuring key messages are clear and concise for clinical study reports.
      • Develop data presentation strategies and messaging standards for clinical documents.
      • Independently author submission documents and collaborate with other writers and experts to implement submission strategies.
      • Work with senior leadership to develop resource plans for clinical submission documents.
      • Stay current on regulatory agency guidelines and drug approval requirements.

    • Cross-Functional Collaboration:

      • Lead cross-functional writing teams, coordinating the development of clinical submission documents in high-priority drug projects.
      • Collaborate with regulatory teams to ensure content strategy supports global drug approval processes.

    Qualifications & Experience

    • Education:
      • Master’s degree in natural sciences (Bachelor’s degree considered for strong candidates).
    • Experience:
      • 5-6 years of experience in regulatory medical writing, with at least 4 years focused on writing submission documents, particularly in oncology.
      • Experience in developing clinical documents for global regulatory submissions (across multiple regions).
      • Strong understanding of drug development processes, clinical study report development, and regulatory requirements.

    Skills:

    • Deep knowledge of clinical data management, regulatory, and drug safety requirements.
    • Expertise in creating clinical documents that meet regulatory standards.
    • Strong writing and communication skills with the ability to collaborate effectively in cross-functional teams.
    • Ability to maintain high-quality document development in a timely manner.

    Benefits

    • Competitive base pay, variable pay, and recognition programs.
    • Comprehensive employee benefits including wellbeing initiatives and family support.
    • Opportunities for continuous learning and professional development.

    Why ICON?
    ICON is committed to fostering a culture of continuous learning, providing employees with engaging work, career development, and a diverse, inclusive environment. We offer a comprehensive reward package and are an equal opportunity employer.

    Interested? Apply now to join a leading clinical research organization, contributing to cutting-edge drug development in the oncology field.

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    Ho Chi Minh City |