Principal Medical Writer
ICON plc is a world‑leading healthcare intelligence and clinical research organization. We foster an inclusive environment and invite you to be part of our mission to shape the future of clinical development.
Overview
We are seeking a Senior or Principal Medical Writer to lead the development of high‑quality regulatory and clinical documents that communicate scientific and medical information. The role supports client submissions to regulatory authorities and ensures compliance with industry standards.
What You Will Be Doing
- Guide medical writing document preparation, coordinate assignments, review and edit documents.
- Assume primary responsibility for key regulatory response documents and documents supporting major regulatory submissions.
- Formulate writing approach, develop timelines, assess resource requirements for key documents and regulatory submissions within designated therapeutic area.
- Participate on project teams and task forces, provide functional and cross‑functional guidance on document preparation, regulatory requirements, style, electronic integrity, and project‑specific guidance.
- Lead writing strategy providing expertise on organization, content, timelines, and resource requirements.
- Provide advanced input for study designs, analysis plans, sections of INDs and marketing applications.
- Review and substantively edit contributions, ensuring resolution of issues.
- Manage deliverables and prepare documents for submission to regulatory agencies, ensuring consistency across therapeutic areas and adherence to regulatory and sponsor requirements.
- Represent Medical Writing on cross‑functional teams and task forces.
- Act as a key medical point of contact for clinical regulatory strategy.
- Serve as lead writer for important regulatory response documents and key components of regulatory submissions.
- Provide leadership on functional teams addressing requirements or issues related to document preparation and production.
- Perform work independently with minimal supervision.
Your Profile
- Bachelor’s degree in science or health profession (required).
- At least 5 years of experience writing for pharma or biotechnology (preferred); 3+ years of electronic documents and submissions (required).
- Experience writing key documents included in major international regulatory submissions such as Clinical Study Reports, Investigational Brochures, and Protocols (required).
- Experience managing writing activities for a major international regulatory submission (preferred).
Knowledge and Skills
- Clear understanding of clinical development phases, processes, and techniques from protocol design through regulatory submission and support for marketed products.
- Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production (including CTDs).
- Well‑developed oral and written communication skills; ability to present technical information clearly across functional areas.
- Demonstrated problem‑solving and interpersonal skills that facilitate effective interactions within functional and cross‑functional teams and with external providers.
Benefits
- Competitive salary.
- Annual leave entitlements.
- Health insurance options.
- Retirement planning offerings.
- Global Employee Assistance Programme.
- Life assurance.
- Optional benefits such as childcare vouchers, bike schemes, gym memberships, travel passes, health assessments.
Equal Opportunity Statement
At ICON, inclusion and belonging are fundamental to our culture and values. We are committed to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If you need a reasonable accommodation for any part of the application process, please let us know.
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