About the Role
This role involves leading the creation and finalization of high-quality documents required for regulatory submissions, working closely with cross-functional teams and serving as the primary medical writing contact for a single sponsor.
Responsibilities
- Lead the planning and execution of regulatory documents for assigned projects
- Serve as the main point of contact for medical writing within the sponsor team
- Ensure all documents meet regulatory standards and client expectations
- Collaborate with clinical, statistical, and pharmacovigilance experts during document development
- Develop timelines and manage deliverables for submission timelines
- Review protocols, clinical study reports, and integrated summaries
- Provide scientific and strategic input during document planning
- Mentor junior writing staff and ensure consistency in output
- Conduct quality checks and ensure adherence to style guides
- Coordinate input from multiple stakeholders across functions
- Support responses to regulatory agency questions
- Ensure compliance with global regulatory requirements
- Manage document version control and review cycles
- Participate in sponsor meetings and project strategy discussions
- Oversee the preparation of briefing books and meeting materials
- Ensure consistency of data presentation across documents
- Lead document drafting for Investigational New Drug applications
- Support development of New Drug and Biologics License Applications
- Maintain up-to-date knowledge of regulatory guidelines
- Train team members on best practices in medical writing
- Optimize processes to improve efficiency and quality
- Ensure accurate representation of clinical data
- Work within tight deadlines typical of submission timelines
- Support cross-therapeutic area initiatives as needed
- Promote clear and concise scientific communication
Compensation
Competitive market rate based on experience
Work Arrangement
Hybrid or remote with regional flexibility
Team
Integrated team supporting pharmaceutical development and regulatory milestones
Why This Role Matters
This position plays a critical role in advancing drug development by ensuring regulatory documents are scientifically sound, compliant, and submitted on time. The writer will directly influence the success of key submissions for an important sponsor.
What You’ll Bring
A track record of leading complex writing projects, deep regulatory knowledge, and the ability to serve as a trusted partner to clinical teams. You should thrive in a dynamic setting and be committed to quality and precision.
Not specified
