Principal Medical Writer preparing regulatory documents and medical communications for Veristat, a clinical research organization accelerating life - changing therapies. Supporting product development through scientific analysis, ICH compliance, and cross - functional document collaboration.
About the role
- Senior Medical Writer leading clinical regulatory and clinical document authorship for Veristat, a life-sciences consultancy accelerating therapies. Managing projects, teams, clients, and submission deliverables.
Responsibilities
- Contribute to authorship of clinical and regulatory documents across different service lines
- Lead smaller projects as project lead and interface directly with clients
- Support larger, more complex engagements as part of a larger delivery team
- Lead internal project teams and anticipate the effects of writing conventions on health authority approval or acceptance
- Develop submission-level documents
- Develop clinical documents such as Clinical Study Reports, Investigator Brochures, protocols, ISS, and ISE
- Synthesize data across multiple sources and documents to create summary reports
- Conduct or lead a CRM and lead project teams to consensus
- Present ideas and suggestions using logical arguments while responding constructively to opposing views
- Develop professional client relationships to support business relationships and maintain industry knowledge
- Identify and institutionalize effective work practices to ensure consistent performance
Requirements
- Bachelor’s degree
- 3+ years of regulatory writing experience or equivalent experience with clinical-related documentation
- Understanding of regulatory authority guidelines and requirements
- Experience developing submission-level documents
- Experience developing Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE
- Intermediate proficiency with Microsoft Word, including editing tools, creating and modifying tables, and inserting figures
- Knowledge of document management techniques
- Strong understanding of the document creation process and drug development lifecycle
- Ability to synthesize data across multiple data sources and documents
- Ability to conduct or lead a CRM and lead a project team to consensus
- Ability to use logical arguments to persuade others and respond positively to opposing views
- Ability to develop professional client relationships
- Ability to identify and institutionalize effective work practices
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
- Applicable bonus
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