Medical Writer developing clinical protocols and regulatory documents for Syneos Health’s life sciences clients. Partnering with Clinical Scientists across oncology, hematology, and cell therapy studies.
About the role
- Principal Medical Writer leading CMC regulatory submissions for Veristat’s life-sciences clients. Authoring Modules 3 and 2.3 while guiding project teams and mentoring regulatory writers.
Responsibilities
- Prepare high-quality regulatory documentation for client submissions
- Contribute to authorship of documents across different service lines
- Lead projects and author regulatory documents for client engagements
- Mentor others in regulatory document authoring
- Author and lead Modules 3 and Module 2.3
- Serve as document lead for submission-level documents
- Provide subject matter guidance on document preparation, review, comment resolution, and finalization
- Lead project teams toward goals within timelines and budgets
- Build professional client relationships and support business relationships
- Identify and institutionalize effective work practices
- Resolve sensitive or high-pressure project problems
- Transfer knowledge across the organization
Requirements
- Bachelor’s degree or higher, scientific discipline strongly preferred
- 7+ years of regulatory writing experience with Chemistry, Manufacturing, and Controls documentation
- Experience in vaccines, gene/cell therapy, biologics, small molecule, manufacturing, analytical, or stability
- Experience with NDAs, INDs, BLAs, or IMPDs
- Experience authoring and leading Modules 3 (e.g., Modules 3.2.S and 3.2.P) and Module 2.3
- Understanding of regulatory authority guidelines and requirements
- Ability to lead a project team
- Understanding of regulatory requirements for different phases of development and regulatory pathways
- Knowledge of global health authority requirements
- Experience as a document lead in submission-level documents
- Intermediate proficiency with Microsoft Word, including editing tools, creating and modifying tables, inserting figures, and document management techniques
- Strong understanding of document creation processes and the drug development lifecycle
- Ability to synthesize data across multiple sources and documents to create summary reports
- Expertise in quality document preparation, document review, comment resolution/incorporation, and document finalization
- Ability to own submission-level documents and lead others toward common goals within timelines and budgets
- Understanding of communication best practices
- Solid time management and organizational skills
- Ability to develop professional client relationships and maintain current industry knowledge
- Ability to identify and institutionalize effective work practices
- Ability to resolve problems in sensitive or high-pressure situations
- Ability to transfer knowledge and strengthen organizational capabilities
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
- Applicable bonus
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