- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the scientific ... to lead preparation, review, and finalization of CMC documents for global regulatory submissions, including Clinical Trial Applications, Market Authorization… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs , Global Regulatory ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in forums that share… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory ... behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructivelychallengeteams to reachthebest… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive ... experienced Medical Director of CNS Early Assets, Global Medical Affairs , responsible for certain assets...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… more
- American Express (Indianapolis, IN)
- …this role?** Help propel your team and its business partners to success. Our Global Government Affairs office represents the company on important public policy ... issues around the world. Global Government Affairs colleagues work with departments...+ In collaboration with VP, State & Local Government Affairs , identify, assess and influence legislative and regulatory… more
- Lilly (IN)
- …innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Engage in forums that ... risk, and improve efficiency in drug development. The purpose of the Sr. Director - GRA Global Regulatory Policy & Strategy - Oncology role is to elicit,… more
- Merck (Indianapolis, IN)
- …Development Teams and the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** The Director /Principal Scientist, Regulatory Affairs ...Compliance Programs, Cross-Functional Teamwork, Drug Development, Economic Impact Analysis, Global Regulatory , Regulatory Affairs… more
- Cardinal Health (Indianapolis, IN)
- …of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + ... brand for post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …science, data management, and medical writing. + Experience with the global regulatory requirements. Demonstrated experience in successful regulatory ... and nutraceutical products for the maintenance of everyday health We are seeking a Director , Global Clinical Development (GCD) who will be responsible for the… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …data management, and medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory ... **Job Description** Otsuka is seeking a Director , Global Clinical Development (GCD), who...as an clinical/medical scientific consultant to health economic, medical affairs , marketing, regulatory , statistical and other research… more
- Lilly (Indianapolis, IN)
- …BU Medical, other MDU Functions, Clinical Development (early and late phase), Regulatory Affairs - North America and International, regional/affiliate brand ... for the technology, systems, automation, and analytics strategy across Global Patient Safety, globally. The Sr. Director ...who are subject to considerable turnover within and between regulatory reporting cycles + Monitor and evaluate global… more
- Cook Medical (Bloomington, IN)
- …will be seen by internal and/or external customers. Collaborates with Regulatory Affairs , Reimbursement, Commercial, Research and Development, Marketing, Product ... regulatory submissions, product development, internal and external training, global reimbursement efforts, market research, and sales and marketing efforts. Key… more
- Lilly (Indianapolis, IN)
- …+ Experience in Manufacturing, Development, QC, Technical Services, Engineering and/or Regulatory Affairs . + Understanding of statistical tools and analysis. ... 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)
- …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 ... determined to make life better for people around the world. **Associate Director , Customer Personalization Insights & Analytics** **Company Overview** At Lilly, we… more
- IQVIA (Indianapolis, IN)
- **MSL Associate Director ** We are excited to announce that currently we are looking for **Medical Science Liaison Associate Director and Player-Coach** with ... insight to inform decision making on various aligned teams. The **MSL Associate Director & Player Coach** will have all of the functional responsibilities of the… more
- Grifols Shared Services North America, Inc (South Bend, IN)
- …regulatory filings (IND, study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions + Serve as program medical expert ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...than 110 countries and regions. **Position Overview:** The Medical Director will be responsible for clinical strategy relating to… more
- Lilly (Indianapolis, IN)
- … regulatory compliance + Advanced degree or certifications in Quality Management, Regulatory Affairs , or related discipline + Proven track record of deploying ... 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
- Sumitomo Pharma (Indianapolis, IN)
- …Medical Affairs , Market Access, Omnichannel, Patient Marketing, Legal, and Regulatory to ensure unified execution and strategic cohesion. + Lead co-promotional ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and **clinically fluent commercial leader** for the role of ** Director , HCP Marketing - Orgovyx** . Reporting to the… more
- CSL Plasma (Hobart, IN)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... as or delegates to another appropriate physician the duties of "laboratory director ", "technical consultant", or "clinical consultant" as prescribed by the Clinical… 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