What are the responsibilities and job description for the Regulatory Project Manager position at Advanced Clinical?
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Regulatory Project Manager in Foster City, CA. The Regulatory Project Manager role will be responsible for supporting project communications, conducting follow-up with project team members, partners or stakeholders, tracking project information, helping maintain project timelines, and performing other administrative work to support RPM colleagues and project team members. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
- Manages basic department / cross-functional specific programs and / or initiatives.
- Manages basic project / initiative communications and works in partnership with senior-level Project Management to ensure that all stakeholders are fully informed and knowledgeable of project activities and their status.
- Provides Regulatory Project Management support for assigned programs / projects / initiatives; may attend sub-team meetings.
- Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate.
- Identifies and manages critical path activities.
- Supports 1 - 2 Regulatory Projects, including but not limited to cross-reference INDs, original INDs, and simpler RTQs.
- In relation to regulatory submissions, tracks and prepares project information and activities, including minutes, timelines, action items and function-specific deliverables. Ensures integration of project timing, scope and resources.
- Works in partnership with senior-level Project Management and / or Project Lead to ensure timely, efficient and effective meetings and progress on activities between meetings.
- Works in partnership with senior Project Manager and / or Project Lead to execute on deliverables.
- May coordinates basic team operations and communications.
- Works with senior Project Management to generate periodic project team and sub-team updates and assists with preparation of formal presentations as required.
- May implement routine process improvement and optimization initiatives as required.
- May manage sub-projects as assigned.
- Focuses on operational tasks, learns how to manage submissions independently, and starts to develop a strategic mindset.
- Ensures project work complies with established practices, policies and processes and any regulatory or other requirements
EXPERIENCE & EDUCATION
To be a best-fit your strengths must include :
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http : / / www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
