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Job Description
- Req#: 120531
- Developing and authoring clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.
- Ensuring all documents comply with regulatory guidelines and company standards for quality and accuracy.
- Collaborating with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to gather and interpret clinical data.
- Mentoring and guiding junior medical writers, fostering a culture of excellence and continuous improvement.
- Reviewing and editing documents prepared by other writers to ensure consistency and adherence to regulatory requirements.
- Staying current with industry trends and regulatory changes to integrate best practices into medical writing processes.
- Contributing to the development of templates, style guides, and standard operating procedures to enhance the efficiency and quality of medical writing activities.
- A master’s degree or Ph.D. in Life Sciences, Medicine, or a related field.
- Extensive experience in medical writing, with a proven track record of developing clinical and regulatory documents in the pharmaceutical or biotech industry.
- Strong proficiency in scientific writing and editing, with excellent attention to detail.
- Excellent analytical and problem-solving skills, with the ability to interpret complex clinical data and present it clearly.
- Demonstrated leadership skills, with experience in managing and mentoring teams effectively.
- Exceptional communication skills, with the ability to convey technical concepts to diverse audiences.
- Detail-oriented, with strong organizational skills to manage multiple projects and deadlines in a dynamic environment.
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
Overview
We are currently seeking a Senior Principal Medical Writer to join our diverse and dynamic team. As a Senior Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality clinical and regulatory documents, ensuring clarity, accuracy, and compliance with industry standards.
Responsibilities
What You Will Be Doing:
Qualifications
Your Profile:
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:
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt 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, colour, 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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.
About the company
We are a global healthcare intelligence partner with everything you need to take your assets from concept to compound to cure.
Notice
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