- Takeda Pharmaceuticals (Indianapolis, IN)
- …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... seeking Regulatory Scientist GRA-CMC to be a part of the Lilly global regulatory group to support global registrations and lifecycle management for our… more
- Sumitomo Pharma (Indianapolis, IN)
- … Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Merck (Indianapolis, IN)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... Support device design control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices and combination products,… more
- Sumitomo Pharma (Indianapolis, IN)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...member of the Medical Affairs team reporting to the Executive Director ,… more
- Sumitomo Pharma (Indianapolis, IN)
- …Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains… more
- Sumitomo Pharma (Indianapolis, IN)
- …, Medical Strategy (Prostate Cancer)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties… more
- Lilly (Indianapolis, IN)
- …journey " and the strategic plan for the compound ), medical support for regulatory affairs and interactions with government agencies (medical support for New ... with the strategic priorities of the respective business unit global Medical Affairs team, brand team (s...of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory , and legal.… more
- Lilly (Indianapolis, IN)
- …and volunteerism. **Purpose:** The Associate Vice President (AVP) - Cardiometabolic Health Global Medical Affairs drives strategic planning and, through clinical ... activities are clearly aligned with the strategic priorities of the Cardiometabolic Health Global Medical Affairs team(s), brand team(s), and global … more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …Regulatory Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …and infrastructure in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology roadmap. + Promotes regulatory ... shared goals. + Demonstrates leadership and a deep understanding of global regulatory affairs (GRA) information/data regulations and guidelines, proactively… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates ... patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Black & Veatch (Indianapolis, IN)
- ** Global Benefits Director ** Date: Jan 23, 2025 Location: Overland Park, KS, US US Company: Black & Veatch Family of Companies **Together, we own our company, ... questions and put your diverse talents and perspectives to use. **The Opportunity** The ** Global Benefits Director ** will have the opportunity to: + Lead the… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- Sumitomo Pharma (Indianapolis, IN)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The **Executive Director Head of Medical Strategy** will be a key… more
- Lilly (Indianapolis, IN)
- …Research and Access Programs is accountable for partnering with drug development teams, Global Regulatory Affairs (GRA), Clinical, CM&C, and the broader ... following areas: pharmacy, drug development, clinical drug development, CT material, CM&C, global regulatory affairs , quality, or commercial manufacturing +… more
- Sumitomo Pharma (Indianapolis, IN)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** Director , MSL Lead, Oncology will be responsible for integrating… more
- Lilly (Indianapolis, IN)
- …and Sr. Medical leaders + Pricing, Access, and Reimbursement + New Product Planning + Global Marketing director or manager + Global patient safety + External ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Merck (Indianapolis, IN)
- …ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory , Pharmacovigilance (PV) and Medical Affairs . + Responsible and ... **Job Description** The Clinical Research Director (CRD) is the Clinical Operations lead in...delivery. + A complete understanding of ICH GCP and Global /Regional/Local regulatory requirements is required. + Strong… more