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    Principal Medical Writer

    Icon Plc
    7+ years
    Not Disclosed
    Remote - Europe
    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: Remote
    Company: ICON plc

    Role Overview

    ICON is seeking a Principal Medical Writer to work with a global pharmaceutical client, providing key expertise in medical writing and regulatory submissions. This role offers the opportunity to collaborate in a fast-paced, evolving environment, contributing to industry-changing projects while advancing your career development.

    Key Responsibilities

    • Medical Writing Expertise:
      • Guide and coordinate the preparation of medical writing documents, including regulatory response documents and submission materials for major regulatory submissions.
      • Formulate writing strategies, create timelines, and assess resource requirements for key regulatory documents within a therapeutic or functional area.
      • Lead cross-functional teams to ensure high-quality document preparation, adhering to international regulatory guidelines and requirements.
      • Act as a primary medical point of contact for clinical regulatory strategy and serve as the lead writer for key documents such as Clinical Study Reports (CSRs), Investigator Brochures (IBs), and Protocols.
      • Manage deliverables and document preparation for submission to regulatory agencies, ensuring content consistency and adherence to sponsor and regulatory requirements.
      • Provide leadership on functional teams addressing document preparation and production requirements.

    Qualifications & Experience

    • Education:
      • Bachelor’s degree in science or health profession.
    • Experience:
      • At least 7 years of experience in writing for the pharmaceutical or biotechnology industry.
      • 3+ years of experience in electronic documents and regulatory submissions.
      • Experience as a lead writer for key documents in major international regulatory submissions.
      • Strong understanding of clinical development phases, regulatory processes, and ICH guidelines.

    Skills & Knowledge

    • Deep knowledge of clinical development, including protocol design through regulatory submission.
    • Expertise in international regulations, ICH guidelines, and applicable regulatory processes.
    • Strong written and verbal communication skills to clearly present complex technical information.
    • Proven problem-solving and interpersonal skills, with the ability to work effectively across teams.

    Benefits

    ICON offers a comprehensive benefits package including:

    • Various annual leave entitlements
    • Health insurance options for you and your family
    • Retirement planning offerings
    • Global Employee Assistance Programme
    • Life assurance and flexible, country-specific benefits such as childcare vouchers, gym discounts, and more.

    Why ICON?
    At ICON, our diverse workforce drives our success. We prioritize performance, innovation, and career development, offering a work environment that fosters inclusion and well-being. ICON is committed to providing an accessible, discrimination-free workplace.

    Interested?
    If you're excited about this opportunity but unsure if you meet all the qualifications, we encourage you to apply. ICON is committed to finding the right talent for our team. Apply today and take the next step in your career with ICON!

    For more information, visit ICON Careers.

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    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |