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Principal Medical Writer

5+ years
Not Disclosed
10 Nov. 8, 2024
Job Description
Job Type: Full Time Remote 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. We are committed to transforming clinical development and improving patient outcomes globally. At ICON, we foster an environment of innovation and professional growth, making it an ideal place for talented individuals to build a rewarding career.


Role Overview

As a Principal Medical Writer at ICON, you will lead a team responsible for medical writing activities within a designated therapeutic or functional area. You will provide expertise in regulatory submissions and response documents, ensuring that all deliverables adhere to the highest standards and meet regulatory requirements. In this role, you will also lead writing strategies, manage timelines, and work closely with cross-functional teams to contribute to the success of clinical development programs.


Key Responsibilities

  • Lead Medical Writing Team:

    • Lead a team responsible for key medical writing activities, including regulatory submissions and response documents, ensuring quality and adherence to regulatory requirements.
    • Oversee the preparation and review of key documents, such as study designs, analysis plans, and sections of INDs and marketing applications.
    • Coordinate with contract employees and vendors to review and edit document contributions and ensure resolution of any issues.
  • Regulatory Submissions:

    • Manage the preparation and delivery of documents for submission to the FDA or other regulatory agencies, ensuring consistency and compliance across therapeutic areas.
    • Act as the lead writer for important regulatory response documents and major components of regulatory submissions.
  • Cross-Functional Collaboration:

    • Represent medical writing on cross-functional teams and task forces, contributing to discussions on project strategies, processes, and standards.
    • Provide leadership on functional teams, addressing requirements and issues related to document preparation and production.
  • Writing Strategy & Leadership:

    • Lead the writing strategy, including content organization, timelines, and resource requirements for key documents and submissions.
    • Serve as an expert for complex medical writing tasks, ensuring that the documents meet high-quality standards and regulatory guidelines.

What You’ll Bring

  • Qualifications:

    • Bachelor’s degree in a scientific, health-related field, or journalism required.
    • At least 5+ years of experience in medical writing within the pharma or biotechnology industry.
    • 3+ years of experience with electronic documents and submissions required.
    • Experience as a lead writer for key regulatory documents in US and/or international regulatory submissions.
  • Experience & Skills:

    • In-depth understanding of clinical development, including the phases, processes, and techniques used from protocol design through to regulatory submission and marketed product support.
    • Strong experience in regulatory writing and project management, including overseeing writing activities for large, international submissions.
    • Strong oral and written communication skills to present complex technical information effectively.

Why ICON?

At ICON, our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance, fosters innovation, and nurtures talent. In addition to a competitive salary, we offer:

  • Comprehensive employee benefits including health insurance, retirement planning, and life assurance.
  • A Global Employee Assistance Program offering 24-hour support from a network of specialists.
  • Flexible country-specific benefits, such as childcare vouchers, subsidized travel passes, discounted gym memberships, and health assessments.
  • A commitment to work-life balance, offering various annual leave entitlements and flexible work options.

Diversity & Inclusion

At ICON, diversity, inclusion, and belonging are at the heart of our culture. We embrace a diverse workforce that helps us innovate and deliver better outcomes for our clients and patients. ICON is an equal opportunity employer, committed to providing a workplace free from discrimination. All qualified applicants will receive equal consideration for employment regardless of 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? Apply anyway! We encourage all talented individuals to apply, and you might be exactly what we’re looking for.