- GRAIL (Indianapolis, IN)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders...information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership… more
- Parexel (Indianapolis, IN)
- The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the ... in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and… more
- Coinbase (Indianapolis, IN)
- …management processes. *What you'll be doing (ie. job duties):* * The Senior Associate of Regulatory Change Management (RCM) will support the management, ... connection, and alignment. Attendance is expected and fully supported. The Coinbase Regulatory Change Management (RCM) function is responsible for the… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret ... the impact of regulatory changes to the pharmaceutical environment. **Job Description** +...coordinate projects. + Demonstrates experience interacting with and supporting senior leadership. + Previous experience with people management and… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …Quality Complaints (PQC), Corrective and Preventive Actions (CAPA), Deviations, and Change Control** , ensuring compliance with global regulatory requirements ... **Job Summary** The Associate Director, Global Product Quality - GMP Process...and governance for Product Quality Complaints, CAPA, Deviations, and Change Control processes. Develop and implement global standards, procedures,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- The Associate Director, Scientific Communications manages the execution of the core scientific and medical communications strategy for the relevant therapeutic area ... consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. **Key Responsibilities Include:** **Global… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Position Summary** The Senior Director of TSMS - Technical Agenda is a strategic leadership role within ... agenda projects and initiatives at a product basis through a team of Associate Directors responsible for laboratories and Pilot Plants across the platforms of… more
- Oracle (Indianapolis, IN)
- …and grow your career in this exciting arena. We are looking for a Senior Claims Denial Prevention and Appeals Specialist for providing clinical inputs to engineering ... Clinical AI Agent (CAA). This role leverages expert clinical judgment and regulatory knowledge (eg, medical necessity, level of care, clinical validation) to lead… more
- Lilly (Indianapolis, IN)
- …Biochemistry, Pharmacy, Chemical Engineering) or related field. + Minimum of 5-8 years ( Senior Associate ) or 8+ years (Principal Associate ) of experience ... for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for all products manufactured by third-party partners. Job… more
