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Principal Medical Writer

2+ years
Not Disclosed
9 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 (CRO), powered by healthcare intelligence. We partner with top pharmaceutical companies to provide exceptional service and contribute to healthcare innovation. At ICON, we foster a culture of learning, development, and long-term career growth for our employees, and you’ll have the opportunity to work alongside a global team of experts to make a real difference in healthcare.


Role Overview

As a Principal Medical Writer, you will be dedicated to a Top-5 pharmaceutical company and fully embedded in their drug development programs. In this role, you will have the chance to apply your medical writing expertise while benefiting from ICON’s continued learning and career development opportunities. Your work will directly contribute to the global regulatory submissions for innovative therapies, making a significant impact on patients’ lives.

This remote-based position offers flexibility while allowing you to work at the forefront of the pharmaceutical industry.


What You Will Be Doing

Medical Writing Tasks

  • Develop and write critical clinical documents across various stages of drug development, including:

    • Clinical trial reports (CTRs)
    • Lay summaries of clinical trial results
    • Investigator brochures (IBs)
    • Clinical evaluation plans (CEPs) and Clinical evaluation reports (CERs)
    • Paediatric investigational plans (PIPs)
    • Clinical summary and overview documents in CTD/eCTD format for global regulatory submissions (including IMPDs, INDs, MAAs, NDAs, sNDAs).
    • Responses to regulatory authority questions
    • Deliverables for Advisory Committee Meetings (e.g., briefing books, slides)
    • Publications for scientific journals, including abstracts, posters, and slide presentations for conferences
    • Protocols, Subject Information, and Informed Consent Forms
    • Ad-hoc documents (e.g., meeting packages)
  • Drive discussion and decision-making within cross-functional teams to implement project strategies in documents.

  • Work closely with regulatory and clinical teams to ensure timely and high-quality deliverables.


You Are

Education & Experience

  • PhD or Master’s degree in a relevant scientific or medical field (or equivalent experience).
  • At least 3 years of experience as a medical writer in the pharmaceutical industry or similar field.
  • Experience writing regulatory submission documents is essential.
  • Broad experience with a wide range of medical writing tasks, including clinical trial reports, investigator brochures, regulatory submissions, and more.

Why ICON?

At ICON, we believe that our people are our greatest asset, and we are committed to creating an environment where every employee has the opportunity to excel. We offer a comprehensive total rewards package, including:

  • Competitive base salary
  • Flexible work options and work-life balance
  • Comprehensive health benefits (medical, dental, vision)
  • Global Employee Assistance Programme, offering support to you and your family
  • Retirement planning offerings
  • Life assurance
  • Optional benefits specific to your country, such as childcare vouchers, gym memberships, travel subsidies, and more.

Learn more about the benefits of working with ICON on our career benefits page.


Diversity, Inclusion & Accessibility

At ICON, diversity and inclusion are at the core of our values. We recognize that our diverse workforce makes us more innovative and allows us to better serve our employees, patients, customers, and communities. We are committed to providing an inclusive, accessible environment for all candidates. ICON is an equal opportunity employer, and 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 during the application process or to perform the essential functions of this role, please let us know by submitting a request here.


Interested in the Role?

Not sure if you meet all of the qualifications? We encourage you to apply! At ICON, we value diverse skills and experiences, and you may be exactly what we’re looking for.