- 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 Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… 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
- Lilly (Indianapolis, IN)
- …geographic location. The anticipated wage for this position is $162,000 - $237,600 **Sr. Director - CMH Global Medical Affairs , Incretin T2D HEOR** ... making continues to increase. The purpose of the CMH Global Medical Affairs , IncretinT2D HEOR team is...bold, high impact science. The purpose of the Senior Director is to provide strategic leadership to TA portfolio… 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
- 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
- Sumitomo Pharma (Indianapolis, IN)
- …, Medical Strategy (Women's Health) 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
- Sumitomo Pharma (Indianapolis, IN)
- …. **Job Overview** Director , Field Medical and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner.… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … 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: Dec 25, 2024 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
- 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
- Lilly (Indianapolis, IN)
- …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 ... - $220,000 **Position Responsibilities** : The Lilly Neuroscience Communications Sr. Director will be responsible for driving the internal and external… 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
- Lilly (Indianapolis, IN)
- …EMA) and Good Clinical Practice (GCP) guidelines. + Collaborate with Technical Teams, Regulatory Affairs , and other departments to resolve quality issues and ... This role ensures that clinical trial material is prepared in compliance with regulatory requirements and company standards. The Sr. Director QA collaborates… more
- Lilly (Indianapolis, IN)
- …engagement, genomic testing advocacy). These legal matters may include FDA and global regulatory clinical development, medical affairs , product manufacture ... matters related to: + Regulatory strategies (accelerated approval conversion, global regulatory advice, NILEX strategies, etc.). + Commercial strategy… more