Principal Medical Writer

Icon • Remote, OR

394d

About The Position

As a Principal Medical Writer at ICON, you will be responsible for preparing, writing, editing, and reviewing high-quality regulatory documents for submission to health authorities. This role involves collaboration with project teams and functional contributors to ensure timely and accurate delivery of information. You will also participate in project management, communicate project timelines, and ensure compliance with regulatory requirements while contributing to process improvements.

Requirements

• Bachelor's degree required; Bachelor of Science preferred, or Bachelor of Arts in English or Communications with significant science experience.
• Minimum of 7 years of relevant industry experience in medical/regulatory writing.
• High-level content writing experience and experience with clinical development regulatory documents preferred.
• Excellent written and oral communication skills with attention to detail.
• Knowledge of US and international regulations related to regulatory document preparation.
• Familiarity with Common Technical Document content templates and electronic document management systems.
• Excellent working knowledge of software programs in a Windows environment.

Nice To Haves

• American Medical Writing Association (AMWA) certification or equivalent preferred.
• Relevant advanced degree (e.g., MS, PharmD, PhD, MD) preferred.

Responsibilities

• Prepare, write, edit, and review regulatory documents for submission to health authorities.
• Serve as the RSW representative on project teams and collaborate with functional area contributors.
• Participate in project management for compound programs and RSW projects.
• Communicate deliverables, writing processes, project timelines, and milestones to team members.
• Assimilate and interpret scientific literature and research documentation for regulatory submissions.
• Ensure quality and completeness of information presented in regulatory documents.
• Assist with the coordination of review, approval, and quality control of regulatory documents.
• Communicate timeline and milestone progress to RSW leadership and assess resource needs.
• Comply with conventions, grammar usage, and format requirements per ICH and other guidelines.
• Assist in designing and implementing tactical process improvements.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings
• Competitive retirement planning offerings
• Global Employee Assistance Programme
• Life assurance
• Flexible country-specific optional benefits including childcare vouchers and discounted gym memberships

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree