Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have)

About the role

This remote position focuses on creating high-quality regulatory submission documents that support global filings and align with established industry and client standards. The writer will partner closely with cross-functional teams to manage complex deliverables, coordinate timelines, and ensure content is accurate, compliant, and submission-ready. This position also contributes to process improvement, standardization, and the development of efficient documentation practices across the organization.

Responsibilities

• Develop regulatory documents for global submission in line with ICH and client standards
• Manage medical writing projects, including timelines and cross-functional communication
• Participate in cross-functional meetings to discuss medical writing deliverables and processes
• Review related documents such as protocols and statistical analysis plans as needed
• Engage in cross-functional process improvement initiatives
• Define and write standard operating procedures for efficient document preparation
• Mentor junior medical writing staff and manage internal and contract resources

Qualifications

• Bachelor's degree required; advanced degree preferred in a relevant scientific, clinical, or regulatory field
• Minimum 5 years of medical writing experience in biopharmaceutical, CRO, or comparable clinical/preclinical development
• Proficient in organizing and communicating clinical information with minimal oversight
• Strong organizational, time management, and project management skills
• Excellent verbal, written, and interpersonal communication skills for effective teamwork
• Knowledge of global regulatory requirements and therapeutic areas in clinical development phases is desired
• Proficient in MS Word and experienced with electronic document management systems

Benefits

• Company car or car allowance
• Health benefits including medical, dental, and vision
• 401k company match
• Eligibility for Employee Stock Purchase Plan
• Potential for commissions and bonuses based on performance
• Flexible paid time off (PTO) and sick time

Pay

$114,000 – $210,900 annually

Schedule

Remote — US-based candidates only; no visa sponsorship available