- Takeda Pharmaceuticals (Indianapolis, IN)
- …activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and ... to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is...external CRO partners such as Global Regulatory Compliance, Global Labeling,… more
- 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
- Lilly (Indianapolis, IN)
- …and enable effective decision-making related to molecule development. + Consult on global regulatory strategy, advise on IND/CTA content including gap analysis ... Lilly and LRL operates. The **Senior Director /Executive Director ** is responsible for managing all Regulatory ...college or university + At least 5 years of regulatory affairs experience with research-based drug development,… 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
- 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 (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
- 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
- Merck (Indianapolis, IN)
- …up with the latest regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and ensure submission readiness in all ... **Job Description** The Executive Director , Device Quality & Regulatory will...emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as… 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
- Takeda Pharmaceuticals (Indianapolis, IN)
- …Liaise with and advise study teams including Clinical Science, Data Management, Regulatory Affairs , and other functional areas locally/globally on matters ... of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements. + Good cross-cultural understanding and… 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)
- …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