- 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)
- …life better for people around the world. Purpose: The purpose of the Associate Director , Medical Affairs Intelligence and Analytics role is to implement the ... performing linguistic and semantic text analyses of our customer interactions. The Global Customer Information and Analytics Associate Director will be… more
- Lilly (Indianapolis, IN)
- …discovery + Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs , medical affairs ) If experience is ... of demand realization. In addition, with input from the Director -Medical and Business Unit Team Physician Medical Leader, the...research needs and collaborate with other regions and the global Development and Medical Affairs teams, … 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)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… 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
- ThermoFisher Scientific (Indianapolis, IN)
- …highly motivated and experienced individual to join our team as Global Medical Director , Allergy on the Medical and Scientific Affairs (MSA) team. In this ... quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at...different departments, such as marketing, sales, manufacturing, quality and regulatory affairs . You will also collaborate with… more
- Black & Veatch (Indianapolis, IN)
- ** Global Benefits Director ** Date: Oct 22, 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
- Lilly (Indianapolis, IN)
- …standards and streamline business practices. + Review and approve PK/PD global regulatory submissions and responses, Tox/Drug Disposition/PKPD or Clinical ... protein engineering, CM&C, Medical, Clinical Operations and Design, Statistics, Regulatory Affairs and Therapeutic Area scientists. **Minimum requirements:**… 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)
- …Regulatory Authority questions and annual reports. + Serving as the liaison between CMC/ Regulatory Affairs and Subject Matter Experts on issues related to ... 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
- CSL Plasma (Indianapolis, IN)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA). **Job...CSL to reflect the world around us** As a global organization with employees in 35+ countries, CSL embraces… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …partner with Marketing, Patient Value & Access (PVA), Strategic Account Managers and Medical Affairs . + The National Sales Director (NSD) for the lung franchise ... Marketing, Patient Value & Access (PVA), Strategic Account Managers and Medical Affairs as well as across other sales franchises. **How you will contribute:**… more
- Lilly (Indianapolis, IN)
- …(DCRT), Therapeutic Area Teams, Drug Disposition, Product Development and Regulatory Affairs . **KEY OBJECTIVES/DELIVERABLES:** + Lead Medicinal Chemistry ... 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
- Edwards Lifesciences (Indianapolis, IN)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more