- Cardinal Health (Indianapolis, IN)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions ... knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct...Support research to maintain a pulse on product, supplier, regulatory , and market dynamics; understand how industry trends may… more
- Lilly (Indianapolis, IN)
- …supervision. The Sr. Director must also develop mutually productive relationships with the FDA Office of Prescription Drug Promotion (OPDP), Lilly components and ... across GRA** + Partnering with Therapeutic Directors from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising… more
- Sumitomo Pharma (Indianapolis, IN)
- …a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, guidance ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more
- Merck (Indianapolis, IN)
- …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. + MD or Ph.D./Pharm D… more
- Lilly (Indianapolis, IN)
- …the world. We are seeking a strategic and experienced Senior Director of Drug Supply Chain Security Act (DSCSA) Compliance & Quality to lead our enterprise-wide ... This role will be responsible for ensuring the integrity, traceability, and regulatory compliance of our pharmaceutical supply chain, while also driving continuous… more
- Wolters Kluwer (Indianapolis, IN)
- …metrics. * Leverage knowledge of US healthcare government and regulatory published drug information and policy data sources (CMS, FDA , etc.) covering drug ... **Lead Technology Product Manager** - Commercial Drug Information This role follows a hybrid model,...drug clinical attributes, pricing and reimbursement data, and regulatory classifications-and how these data types are used in… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Lilly (Indianapolis, IN)
- …+ Supports/assists in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), ... reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the… more
- Lilly (Indianapolis, IN)
- …Support/ assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), ... reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the… more