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.
About the role
- Principal Medical Writer leading clinical regulatory documentation for Veristat’s life-science clients. Authoring submissions, leading project teams, and mentoring medical writers.
Responsibilities
- Prepare high-quality documentation for regulatory submissions to streamline the regulatory documentation process for clients
- Contribute to authorship of various documents across different service lines
- Lead projects and contribute as an author for all types of client engagements
- Mentor others in authoring regulatory documents
- Lead submission-level sections for clinical documents, including Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE
- Lead sub-teams for pharmacovigilance and transparency and disclosure deliverables
- Take responsibility for clarity of purpose and lead others toward common goals within timelines and budgets on complex projects
- Manage crisis communications and risks
- Identify and promptly address potential problems, particularly in sensitive or high-pressure situations
- Integrate expertise across multiple therapy areas to deliver business successes and transfer knowledge across the organization
Requirements
- Bachelor’s degree (minimum)
- 7+ years of regulatory writing experience with clinical-related documentation
- Understanding of regulatory requirements for different phases of development and different regulatory pathways
- Knowledge of global health authority requirements
- Experience writing and leading a range of documents in their entirety, including study and submission level and pharmacovigilance documents
- Strong understanding of the document creation process and drug development lifecycle
- Intermediate proficiency with Microsoft Word, including editing tools, creating and modifying tables, and inserting figures
- Experience with document management techniques
- Ability to synthesize data across multiple data sources and documents to create summary reports
- Ability to lead submission-level sections, including Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE
- Ability to lead sub-teams for deliverables, including pharmacovigilance documents and transparency and disclosure deliverables
- Understanding of communication best practices
- Broad experience and technical expertise across more than one therapy area
- Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
- Applicable bonus
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