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    Principal Medical Writer

    Icon
    2+ years
    Not Disclosed
    Remote - Europe
    10 Nov. 8, 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

    About ICON plc

    ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. At ICON, we pride ourselves on fostering a culture of collaboration, innovation, and continuous professional development. Join us and help shape the future of clinical development with our global expertise in healthcare.

    Role Overview

    As a Principal Medical Writer at ICON, you will be embedded with a Top-5 biotech company, working on cutting-edge drug development in the field of autoimmune diseases. This is a home-office-based position where your expertise in medical writing will directly impact the successful delivery of high-quality regulatory and submission documents. You will be a key part of a dynamic team, ensuring the rapid progression of their deep antibody pipeline while benefiting from ICON’s continued learning opportunities and long-term career growth.

    What You Will Be Doing

    Medical Writing Excellence

    • Deliver high-quality clinical, regulatory, and submission documents, including clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, eCTD modules, and other clinical/regulatory documents.
    • Take the lead in advising and guiding clinical teams on content, writing processes, and document development best practices.
    • Ensure all documents adhere to company SOPs and regulatory guidelines.
    • Lead the development of regulatory documents in a multi-stakeholder environment, ensuring seamless delivery and timely project completion.
    • Collaborate with clinical program leadership and clinical teams to set and meet challenging project deadlines.

    Functional Leadership

    • Provide guidance on best practices for medical writing processes within clinical teams, driving consistency in documentation using document templates and the company style guide.
    • Disseminate and apply industry and health authority regulatory guidelines to all documentation processes.
    • Represent medical writing at internal meetings, including project and program management status updates.
    • Proactively recommend process improvements to ensure the highest quality of regulatory document delivery.
    • Represent medical writing during clinical trial document audits, ensuring timely resolution of any findings.
    • Participate in industry standards working groups, advocating for medical writing best practices.

    You Are

    • Experienced: Minimum of 6 years of experience in pharmaceutical/biotechnology medical writing, including the preparation of regulatory and clinical submission documents.
    • Educated: A Master’s degree in a scientific, medical, or clinical discipline is required; a PhD is preferred.
    • Regulatory Expertise: Strong understanding of FDA and ICH guidelines for clinical reporting, with experience in eCTD development and submission preferred.
    • Skilled in Drug Development: A deep understanding of the drug development process, including the creation of clinical study reports, protocols, and other regulatory submissions.
    • Excellent Communicator: Able to effectively drive cross-functional collaborations and articulate complex medical concepts clearly to varied stakeholders.
    • Process-Oriented: Proactive in recommending improvements to medical writing processes and ensuring consistency of documents across indications.
    • Publishing Experience: Experience with electronic publishing and adherence to regulatory document standards.

    Why ICON?

    At ICON, we understand that our success depends on the quality and capabilities of our people. That’s why we prioritize continuous learning and development for our employees. Joining ICON means becoming part of a dynamic, inclusive, and innovative organization that offers:

    • A competitive salary and variable pay structure with recognition programs to reward your contributions.
    • Comprehensive benefits tailored to your needs and those of your family, including health insurance, life assurance, retirement planning, and more.
    • A Global Employee Assistance Program, providing 24/7 access to a network of independent professionals to support you and your family’s well-being.
    • Flexible, country-specific benefits that support your work-life balance, such as childcare vouchers, gym memberships, health assessments, and more.
    • A strong focus on career growth, offering opportunities for you to build a long-term career while making a significant impact in autoimmune disease drug development.

    Diversity & Inclusion

    ICON is committed to building a diverse and inclusive workplace. We believe diversity drives innovation and helps us better serve our employees, patients, customers, and communities. As an equal opportunity employer, we ensure that all qualified applicants are given equal consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

    Accommodations

    If you require reasonable accommodations due to a medical condition or disability to participate in the application process or perform the essential functions of the job, please submit your request here.

    Interested in the Role?

    Not sure if you meet all the qualifications? Don’t hesitate to apply anyway – we value diverse skills and experiences and encourage you to submit your application for consideration!

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