Works directly with GRA Leadership, GRA personnel, as well as PMO and Finance in leading the project review process, raising issues for resolution, ensuring action items are completed, and communicating the health of both project and the portfolio to GRA Leadership. Candidate will work with key leaders to manage the overall performance of the portfolio by interpreting metric and project review information resulting in actionable plans to improve delivery efficiencies to US Labcorp or our clients. Candidate will assume responsibility for GRA business development activities intended to increase business for regulatory services. Additional responsibilities include leading cross-project and financial processes improvements, mentoring teams on improving project performance and taking on special projects as deemed appropriate by GRA Leadership.
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Regulatory Submissions Manager Assistant (Reg Spec III ) provide extensive support to develop client's products, multiple projects at a time, regularly interact and communicate with client staff (including senior client staff) as the client's main point of contact, and must work to high standards with minimal supervision. Reg Spec III work with a variety of global clients, generally virtual or small to mid-sized companies, across all asset types (CDx, IVD, MD, drug, biologic, cell/gene therapy), and across all therapeutic areas.
Essential Job Duties:
- Manage multi-functional regulatory projects. Participate in cross-functional initiatives.
- Involvement in leading proposal and bid defense efforts for regulatory projects where more than one Regulatory function is included.
- Lead Product Development Team, which is a multidisciplinary team, across the entire enterprise for the client's relationship, localization, the drug development goal, etc.
- Contribute to GRA materials for proposal templates, Account Executive training, and GRA capabilities content.
- Identify, promote and implement best practices for GRA driving for sustainable competitive advantage.
- Work with CTMO and GRA Leadership to: Recommend areas of improvement across clients to enhance operational performance, Lead improvement processes and ensure implementation throughout the organization.
- Participate in and/or lead business development activities to increase business for regulatory services and enterprise molecule development work.
- Perform other duties as assigned by GRA Leadership.
Experience:
Minimum Required:
- Master's Degree in Life Sciences or equivalent
- Minimum of 5 years' experiences in the Pharmaceutical / IVD /MD industry in Regulatory Affairs or Drug Development, Medical device development, Diagnostic drug development
- Business level of English and Japanese(including speaking)
#LifeatLabcorp - full time roles
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