Job Description
Principal Medical Writer - United States (Remote)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We have an incredible opportunity for a Principal Medical Writer to join ICON’s Full Service team. The Principal Medical Writer will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients’ success in setting-up and reporting clinical trial results as well as developing submissions to regulatory authorities and ensuring compliance with industry standards. Responsibilities also include carrying out senior-level reviews of all types of deliverables, leading teams with strong organizational and project management skills, identifying ways to improve team efficiency, and a passion for developing documents of highest level of quality and accuracy, and regulatory compliance.
Location: United States - Remote (Pacific and Central Time Zones preferred)
What you will be doing: - Leading preparation and review of clinical study reports (CSRs), protocols, Investigator’s Brochures (IBs), and regulatory submission documents.
- Collaborating with cross-functional subject matter experts (SMEs), including therapeutic experts, clinical research scientists, PK and PD scientists, key opinion leaders, medical monitors, biostatistics leads, regulatory affairs leads, etc. to gather and synthesize information for document development
- Providing guidance across teams on best practices for medical writing and ensuring adherence to local regulatory requirements and internal standards
- Mentoring and training junior medical writers, fostering a culture of collaboration, excellence and professional growth
- Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs
- Maintaining and contributing to a collaborative and collegial environment in our global MW team
Your profile: - 8+ years of experience in medical writing, with a background in leading regulatory submission modules and associated support documents (e.g., PIP/PSPs, IBs, and IMPDs), as well as clinical development documents (e.g., protocols and CSRs)
- Exceptional writing and editing skills, with a keen eye for detail and clarity
- Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders
- Client facing experience, with interest in establishing strong and long-lasting client relationships
- Strong understanding of regulatory requirements and industry standards for regulatory and clinical document development
- Solid understanding of common statistical methods applied in clinical research data analysis, and ability to effectively review a statistical analysis plan and planned output
- A commitment to maintaining high standards of quality and compliance in all medical writing activities
- Acceptance and appreciation for the use of new technologies in document development
- Demonstrated ability to work independently, build positive and productive relationships with teams, proactively address potential project obstacles, maintain constructive demeanor in difficult situations, effectively communicate and propose creative solutions, and set a positive example to customers and colleagues
- Project management skills with the ability to work independently managing deliverables and timelines for multiple studies/projects simultaneously
- Bachelor’s degree in life sciences-related discipline or related field; Master’s degree or Ph.D. preferred
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What ICON can offer you: 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 and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated 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, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Job Tags
Remote job, Permanent employment, Local area, Flexible hours,