- HealthEdge Software Inc (Indianapolis, IN)
- …**Position Overview:** Looking for a subject matter expert in the healthcare regulatory & compliance space, with acumen and passion for leveraging innovative ... our health plan customers in achieving and maintaining compliance with the regulatory bodies that govern them: NCQA (National Committee for Quality Assurance), CMS… more
- Lilly (Indianapolis, IN)
- …manufacturing and initial validations with API EM and CMs. The Sr . Director TS/MS is responsible for leading scientists involved in technical aspects of ... Development, or Administration is desirable. Additional Information: + Must complete ITP for Sr Director TS/MS. + No certifications required. + Tasks require… more
- Lilly (Indianapolis, IN)
- …manufacturing focused scientific capability. The Central API TSMS Director /Executive Director will serve as Manufacturing TSMS senior representative to work ... comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in… more
- Lilly (Indianapolis, IN)
- …comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in ... strategies and manufacturing focused scientific capability. The Central API TSMS Director /Executive Director will provide technical and scientific expertise… more
- Lilly (Indianapolis, IN)
- …of drug substances and drug products. Our chemists, engineers, and scientists develop key technical and business solutions across the portfolio using ... of drug candidates to support clinical trials, product commercialization, and regulatory submissions. The position presents an opportunity to lead dynamic teams… more
- Lilly (Indianapolis, IN)
- …validations, and process optimization for the peptide portfolio, including Mounjaro. The Sr Director leads technical aspects of drug substance manufacturing ... a diverse portfolio of drug substances essential to Lilly! The Central API TS/MS Sr . Director will provide technical and scientific expertise within a dynamic… more
- Lilly (Indianapolis, IN)
- …better for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs, Global Regulatory Lead ... Team (inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists ) and is responsible for forming and maintaining a… more
- Lilly (Indianapolis, IN)
- …right patient using model-informed drug research and development (MIDD). We are seeking a Senior Director to lead a group of PKPD Project Leaders in advancing ... protein engineering, CM&C, Medical, Clinical Operations and Design, Statistics, Regulatory Affairs and Therapeutic Area scientists . **Minimum requirements:**… more
- Lilly (Indianapolis, IN)
- …external manufacturing sites. + Collaborate with process engineers and development scientists to design and transfer robust manufacturing processes to commercial and ... oral communication skills. + Preparation, review, and response preparation of global regulatory submissions ie BLAs and NDAs and other technical communications. +… more
- Lilly (Indianapolis, IN)
- …making medicines. The individual will independently lead projects, supervise scientists , contribute significantly to prioritization of the team objectives, propose ... (DCRT), Therapeutic Area Teams, Drug Disposition, Product Development and Regulatory Affairs. **KEY OBJECTIVES/DELIVERABLES:** + Lead Medicinal Chemistry Group in… more
- KPMG (Indianapolis, IN)
- **Business Title:** Director , Engineering - Innovation **Requisition Number:** 115202 - 34 **Function:** Business Support Services **Area of Interest:** **State:** ... are, join our team. KPMG is currently seeking a Director , Engineering - Innovation to join our Digital Nexus...generative AI model development and management + Collaborate with senior executives and key stakeholders to align model operations… more
- Lilly (Indianapolis, IN)
- …external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and ... SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. + Ensure control… more
- Lilly (Indianapolis, IN)
- …of the therapeutic area group. He/she may delegate some of his/her duties to a Senior Director - Medical. In addition, he/she is responsible for assuring that ... Become a patient advocate, as well as a medical expert. 6. Regulatory / submission responsibilities *Ensures that clinical data generated for regulatory … more