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Principal Medical Writer

6+ years
Not Disclosed
10 Jan. 13, 2025
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

Job Title: Principal Medical Writer
Location: Home-Office Based

About the Role:

As a Principal Medical Writer at ICON, you will be joining the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. In this role, you will support a Top-5 biotech company, helping deliver best-in-class regulatory and submission documents. Your expertise in medical writing will play a key role in accelerating the time to market of their cutting-edge antibody pipeline in the field of autoimmune diseases.

This is a home-office-based position that provides a unique opportunity to be embedded within our client’s team, while still benefiting from ICON’s continued learning opportunities and long-term career development.

What You Will Be Doing:

  • Medical Writing Excellence:

    • Deliver a variety of 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 more.
    • Ensure that all documents are organized, accurate, consistent, and written for the target audience.
    • Take the lead in advising and guiding clinical teams on content and processes, ensuring adherence to company SOPs and regulations.
    • Lead multi-shareholder efforts to ensure the seamless delivery of high-quality regulatory documents.
    • Collaborate with clinical program leadership and teams to manage project deadlines effectively.
  • Functional Leadership:

    • Provide proactive guidance to clinical teams on medical writing processes, ensuring best practices are followed.
    • Drive consistency in documentation across programs by using templates and style guides.
    • Disseminate industry and health-authority regulatory guidelines.
    • Represent medical writing in internal meetings (e.g., project and program management updates).
    • Offer recommendations for process improvements to enhance the delivery of top-tier regulatory documents.
    • Represent the medical writing function during audits of clinical trial documents to ensure timely resolution of findings.

You Are:

  • Experienced:
    • Minimum of 6 years in pharmaceutical/biotechnology-related medical writing.
    • Master’s degree in a scientific, medical, or clinical discipline (PhD preferred).
    • Expertise in FDA and ICH guidelines for clinical reporting.
    • Experience with eCTD development and submission is preferred.
    • Deep understanding of drug development phases, from protocol development through to submission.
    • Strong communication skills and ability to drive cross-functional collaborations.
    • Innovative mindset with a proactive approach to process improvement.
    • Proven ability to proofread and ensure documents comply with internal and external guidelines.
    • Experience in electronic publishing is preferred.

Benefits of Working at ICON:

ICON offers a comprehensive and highly competitive total reward package, including excellent base pay, variable pay programs, and recognition initiatives. We provide best-in-class employee benefits and well-being programs designed to support you and your family throughout your career.

As a key medical writer for a Top-5 biotech company, you’ll also be a full ICON employee, benefiting from continued learning and career development opportunities.

Why ICON?

At ICON, we are committed to fostering a culture of continuous learning, offering you opportunities for professional growth and development. Our inclusive and supportive policies, well-being initiatives, and flexible working options are tailored to meet the needs of you and your family at every stage of your career.

ICON is an equal opportunity and inclusive employer, committed to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you need a reasonable accommodation due to a medical condition or disability during the application process or to perform essential job functions, please let us know.

Interested in the role, but unsure if you meet all of the requirements?
We encourage you to apply regardless. There's every chance you are exactly what we’re looking for, whether for this role or others.