Principal Medical Writer

About This Opportunity

We are representing a confidential biopharmaceutical organization in their search for a Principal Medical Writer. Our talent team at Get A Job.ai partners with innovative companies advancing therapeutic development, and this role offers the chance to contribute to meaningful work in oncology and rare disease treatment.

This is a remote position based in the United States, ideal for an experienced medical writing professional ready to take on complex regulatory and clinical documentation at a senior level.

Responsibilities

• Lead the development of high-quality clinical and regulatory documents including clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, and clinical modules for INDs, NDAs, BLAs, and MAAs
• Manage multiple complex writing assignments simultaneously, ensuring adherence to regulatory guidelines and internal standards
• Serve as medical writing lead for regulatory submissions, coordinating documentation across project teams
• Develop and maintain document templates and writing guidance for regulatory deliverables
• Build collaborative relationships with cross-functional study and program teams
• Identify process improvement opportunities and lead departmental optimization initiatives
• Provide technical mentorship and training to junior medical writers
• Navigate timeline challenges and proactively identify risks with mitigation strategies
• Contribute thought leadership on regulatory writing practices within the department and broader medical writing community

What We're Looking For

• Advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related field preferred
• Bachelor's degree with 5+ years, Master's with 4+ years, or PhD/PharmD/MD with 2+ years of regulatory medical writing experience
• Proven ability to manage complex, multi-document projects with tight timelines
• Strong expertise in critically analyzing, synthesizing, and presenting complex scientific information
• Experience leading filing activities for regulatory submissions
• Technical proficiency in Microsoft Word, Adobe Acrobat, and electronic document management systems
• Demonstrated mentorship and training experience with junior staff
• Excellent communication skills and ability to influence cross-functional stakeholders
• Track record of process improvement and template development
• Occasional travel as needed

How We Work with You

When you apply through Get A Job.ai, our experienced recruiting team will review your qualifications and conduct an initial screening. We'll discuss your background, career goals, and ensure strong alignment with this opportunity. Once we confirm mutual interest, we'll submit your profile directly to our client for consideration. Throughout the interview process, we'll provide guidance and support to help you succeed.

Please apply exclusively through Get A Job.ai. We are the authorized recruiting partner for this search. Direct contact with the hiring organization is not appropriate and may disqualify your application.

Pay

Pay via Get A Job.ai has not been disclosed for this role at this time. Compensation details will be discussed during the screening process.

Get A Job.ai is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and candidates. All employment decisions are based on qualifications, merit, and business needs.