Showing 16 jobs

...calculation and regulatory capital ratios, including data analysis, earnings estimation, and production of external regulatory submissions. • Collaborate with Finance and Lines of Business leaders to understand variance drivers and provide insight to support LOB strategies.

...regularly with the individual PMs to ensure schedule accuracy and clarify schedule issues • Review the contractor’s payment submissions against the completion of work Qualifications Qualifications: • Ability to pass a government background investigation, including financial, criminal, residential, educational, foreign affiliation,...

...regularly with the individual PMs to ensure schedule accuracy and clarify schedule issues • Review the contractor’s payment submissions against the completion of work Qualifications Qualificiations: • Ability to pass a government background investigation, including financial, criminal, residential, educational, foreign affiliation,...

...information and large datasets, including member, pharmacy, claims, laboratory, and provider data to support HEDIS® and state submissions, as well as reporting and analytics projects. This person will provide a strong link between the business customers and the development team, gather and document requirements, perform data...

...administrative requirements of value‐based care programs, including provider agreements/contracts, program documentation & submissions to CMS & other payers, and related requirements. • Lead internal USRC cross‐functional workgroups focused on value‐based product & capability development, including the development...

...Encounter Management application instances including deploying upgrades, making configuration changes, managing day to day submissions operations, building custom tools and utilities, creating adhoc reports / queries • Provide technical support to enterprise clients related to technical and operational aspects of the products...

§ Experienced in authoring, reviewing, and coaching of staff in regulatory filing submissions. § Ability to lead, collaborate and motivate cross functional and matrix teams. § Serve as a key member of the Global Drug Product Technology Transfer team providing expertise and guidance across internal and external network.

• Over $500,000,000 in submissions of large scale facility maintenance contracts with at least 3 deals over $50M closed in the last 5 years. • Valid Driver's License • Ability to travel up to 25% • Demonstrated expertise and success in leading captures and proposals in the services sector with established relationships...

...Commercial and other key stakeholders Filing / Regulatory • Represent Medical Affairs in development of regulatory documents and submissions (e.g. briefing books, protocols, label discussions etc.) • Represent Medical Affairs at FDA/EMA meetings Integrated Evidence Package • Leads the Integrated Evidence Team for development...

...implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts. • Follow FDA submission requirements in consideration of BARDA Program Divisions and the regulatory operational requirements of BARDA core services including clinical, nonclinical, and manufacturing network services.

• Lead clinical contributions to pre-IND and IND submissions (and other stage-appropriate Regulatory submissions) • Lead clinical contributions to Phase 1 study protocols and trial- related documents. • Serve as Medical Monitor on Phase 1 trials.

• Ensure regulatory processes and guidelines are followed, includingco-authoring, and reviewing regulatory submissions to the US Food and Drug Administration (FDA) • Author, review, develop Request for Task Orders (RTORs) and evaluate Clinical Research Organization (CRO) proposals.

• Driving engaging with owners using cooperatives to drive project submissions and customer satisfaction. • Utilize Salesforce to manage and track sales activities, customer interactions, and pipeline development. • Use SalesLoft to automate and optimize outreach efforts, ensuring timely and effective communication with potential...

• Driving engaging with owners using cooperatives to drive project submissions and customer satisfaction. • Utilize Salesforce to manage and track sales activities, customer interactions, and pipeline development. • Use SalesLoft to automate and optimize outreach efforts, ensuring timely and effective communication with potential...

...an understanding of all types of non-clinical studies and how this data fits into overall vaccine development, regulatory submissions, and licensure • Strong expertise in animal models, animal ethics policies, experience with US FDA Animal Rule, non-clinical immunology, correlates of protection, mode of action and safety; experience...

• Review supported industry partner submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. • Monitor supported industry partner project timelines for FDA submission. • Participate or act as regulatory representative on various cross-functional teams, as assigned.