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Principal Medical Writer

2+ 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 advancing global healthcare through innovative solutions, and we’re proud to foster a culture of inclusion, collaboration, and continuous development. Join us and become part of our mission to shape the future of clinical development.


Role Overview

As a Principal Medical Writer at ICON, you will act as the medical writing expert for assigned drug projects, driving the content strategy for regulatory submission documents. You will lead the development of key clinical documents in collaboration with cross-functional teams, ensuring consistency, regulatory compliance, and alignment with clinical development plans. This role is critical to supporting high-priority drug projects that are on the critical path to regulatory submission and approval.


Key Responsibilities

  • Content Strategy and Document Development:

    • Act as the medical writing expert for assigned drug projects, leading the development and implementation of the content strategy for clinical submission documents (e.g., Safety Summaries, Efficacy Summaries, Clinical Overviews).
    • Develop and validate study protocols, clinical study reports (CSRs), and other regulatory submission documents in line with the Clinical Development Plan.
    • Lead the development of project-level data presentation strategies and messaging standards.
  • Leadership and Collaboration:

    • Independently author regulatory submission documents, working closely with assigned writers and cross-functional experts to develop and implement submission authoring strategies.
    • Collaborate with the Head of Medical Writing Oncology to develop resource plans for all clinical submission documents of assigned drug projects.
    • Lead cross-functional writing teams in support of high-priority drug projects.
  • Regulatory Expertise:

    • Stay up-to-date on regulatory agency medical review guidelines and drug approval requirements, ensuring documents are aligned with global standards.
    • Ensure clinical submission documents meet the regulatory requirements for drug approval across multiple regions.

What You’ll Bring

  • Experience:
    • 5-6 years of experience in regulatory medical writing, with at least 4 years focused on writing submission documents such as Safety Summaries, Efficacy Summaries, Clinical Overviews, and similar, preferably within oncology.
    • Proven experience developing clinical documents to support global regulatory submissions, including multiple regions.
  • Education:
    • A Master’s degree in natural sciences is preferred; strong candidates with a Bachelor’s degree will also be considered.
  • Skills & Knowledge:
    • In-depth understanding of the drug development process, with specific knowledge of clinical study report development, regulatory requirements, drug safety, and clinical data management.
    • Strong leadership and project management skills, with the ability to work independently and lead cross-functional teams.

Why ICON?

At ICON, our success depends on the quality and capabilities of our people. That’s why we invest in developing our employees and fostering a culture of continuous learning. In addition to a competitive salary, we offer:

  • Comprehensive benefits package, including health insurance, retirement planning, and life assurance.
  • A Global Employee Assistance Program, providing 24/7 access to support for you and your family.
  • Flexible and competitive country-specific benefits, including childcare vouchers, discounted gym memberships, subsidized travel passes, and more.
  • A strong focus on work-life balance, with generous annual leave entitlements.

Diversity & Inclusion

ICON is committed to diversity, inclusion, and belonging. We believe in the power of a diverse workforce to drive innovation and improve outcomes for patients. As an equal opportunity employer, we provide a workplace free from discrimination and encourage all qualified applicants to apply, 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?

If you’re unsure whether you meet all the qualifications, we encourage you to apply anyway! You might be exactly what we’re looking for, and we value your interest in joining our team.