About the Role
Principal Medical Writer
Join the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. As a Principal Medical Writer, you will be responsible for driving the development and implementation of clinical submission documents for high-priority drug projects, playing a crucial role in supporting drug submission and approval processes.
What You Will Be Doing
Act as the medical writing expert for assigned drug projects, leading the planning, development, and implementation of content strategies for clinical submission documents, with input from appropriate expert functions.
Drive the design of clinical submission documents in support of the Clinical Development Plan (CDP), ensuring key messages in clinical study protocols and clinical study reports (CSRs) are accurately conveyed.
Lead the development of project-level data presentation strategies and messaging standards.
Independently author submission documents and collaborate with assigned writers and submission team experts to develop and implement the authoring strategy for all clinical documents.
Work with the Head of Medical Writing (Oncology) to develop and implement authoring resource plans for all clinical submission documents for assigned drug projects.
Stay updated on regulatory agency medical review guidelines and drug approval requirements relevant to assigned projects.
Take responsibility for developing the regulatory submission content strategy and leading cross-functional writing teams supporting high-priority drug projects, ensuring timely submission and approval.
Your Profile
Experience: 5-6 years in regulatory medical writing, with at least 4 years of experience in writing submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.), ideally in oncology.
Qualifications: Master’s degree in natural sciences preferred; strong candidates with a Bachelor’s degree will also be considered.
Expertise:
Extensive experience in developing clinical documents to support regulatory submissions globally (across multiple regions).
A thorough understanding of the drug development process, including clinical study report development, regulatory and drug safety requirements, and clinical data management and statistical functions.
Knowledge of regulatory submission processes and familiarity with drug approval requirements in various global markets.
Why ICON?
ICON is committed to offering a comprehensive and competitive total rewards package, which includes an excellent base pay, variable pay, recognition programs, and best-in-class employee benefits. Our supportive policies and well-being initiatives are designed to support you and your family at every stage of your career, now and in the future.
Our success depends on the knowledge, capabilities, and quality of our people. That’s why we’re dedicated to fostering a continuous learning culture, where you’ll be challenged with engaging work, and every experience contributes to your professional growth.
ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
If you require a reasonable accommodation due to a medical condition or disability during any part of the application process, please let us know.
Apply Now
Not sure if you meet all the requirements? We encourage you to apply anyway—there’s a good chance you’re exactly what we’re looking for at ICON, whether for this or other roles.
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