About the Role
Principal Medical Writer
As a Principal Medical Writer, you will be dedicated to supporting one of our global pharmaceutical clients, playing a pivotal role in a unique partnership that redefines collaboration. This opportunity is perfect for individuals who thrive in an evolving environment and are committed to career development within a culture that mirrors ICON's dedication to excellence.
Key Responsibilities
Lead the preparation of medical writing documents, including coordinating assignments to writers, reviewing, and editing documents as necessary.
Assume primary responsibility for key regulatory response documents and major regulatory submissions, ensuring they are well-organized and meet the required standards.
Develop writing strategies, timelines, and resource plans for key documents and regulatory submissions within your designated therapeutic or functional area.
Participate in project teams, offering expertise on document preparation, including international regulatory requirements for content, format, and process.
Provide advanced input on study designs, analysis plans, sections of INDs (Investigational New Drug applications), and marketing applications.
Review contributions and provide substantive editing, ensuring the resolution of any issues.
Oversee the preparation and submission of documents to regulatory agencies, ensuring consistency across therapeutic areas and adherence to regulatory and sponsor requirements.
Serve as a key point of contact for clinical regulatory strategy.
Lead writing for important regulatory response documents and key components of regulatory submissions.
Provide leadership within functional teams addressing document preparation and production requirements.
As a Principal Medical Writer, operate independently, providing expert guidance with minimal supervision.
Your Profile
Education: Bachelor’s degree in a science or health-related field required.
Experience:
At least 7 years of medical writing experience within the pharmaceutical or biotechnology industry.
A minimum of 3 years of experience working with electronic documents and submissions.
Proven experience as a lead writer for major international regulatory submissions, including Clinical Study Reports, Investigator’s Brochures, and Protocols.
Experience managing writing activities for large international regulatory submissions is preferred.
Knowledge & Skills
Strong understanding of clinical development processes from protocol design to regulatory submission and post-market product support.
In-depth knowledge of international regulations, ICH guidelines, and applicable regulatory processes related to document preparation, including CTDs (Common Technical Documents).
Exceptional oral and written communication skills with the ability to clearly present complex technical information across functional teams.
Strong problem-solving and interpersonal skills, facilitating effective interactions within functional teams and with external stakeholders.
What ICON Offers
ICON’s success is built on the quality of our people, and we are committed to fostering a diverse culture that values high performance and nurtures talent. In addition to a competitive salary, we offer a range of benefits designed to promote well-being and work-life balance for you and your family, such as:
Generous annual leave entitlements.
Health insurance options tailored to you and your family’s needs.
Competitive retirement planning benefits.
Global Employee Assistance Programme (TELUS Health) providing 24/7 access to over 80,000 specialists.
Life assurance.
Country-specific optional benefits, including childcare vouchers, bike schemes, gym discounts, and health assessments.
For more information, visit our careers website to explore the full range of benefits: ICON Benefits.
Diversity & Inclusion
At ICON, diversity, inclusion, and belonging are central to our values. We believe that diversity drives innovation and helps us better serve our people, patients, customers, and communities. We are committed to providing an inclusive environment where all candidates are valued, and we ensure a workplace free of discrimination and harassment.
If you require reasonable accommodations due to a medical condition or disability, please submit your request here: Reasonable Accommodations.
Apply Now
If you’re interested in this role but aren’t sure you meet all the requirements, we encourage you to apply anyway—there’s a good chance you’re exactly what we’re looking for, whether for this or other roles at ICON.
Current ICON Employee? Click here to apply.
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