Description
Syneos Health is seeking a Sponsor Dedicated GRO RPSM – Regulatory Submissions Coordinator Manager to join their team.
The successful candidate will be responsible for creating and maintaining content plans within Veeva Vault RIM, translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM, and assisting with planning, managing, and tracking of regulatory submissions.
Key responsibilities include:
- Creating and maintaining content plans within Veeva Vault RIM
- Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM
- Assisting with planning, managing, and tracking of regulatory submissions
- Supporting Vertex Global Submission Managers with project management activities, tasks, and tracking
- Assisting with coordination and communication of regulatory submissions to Vertex Publishing
- Working with firm deadlines and adapting quickly to changing requirements and priorities
- Excellent organization, written/verbal communication, and attention to detail
- Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems
- Experience with project management tools and software, including Smartsheet, Microsoft Project, Excel, and Office timeline Pro
The ideal candidate will have a B.S. or equivalent experience and 5+ years of Regulatory Affairs Work Experience, with a focus on publishing and/or submissions, or an M.S. or equivalent experience and 3+ years of Regulatory Affairs Work Experience, with a focus on publishing and/or submissions.
In-depth understanding of regulatory requirements and guidelines, including FDA regulations, EMA guidelines, and ICH standards, is also required.