- Lilly (Indianapolis, IN)
- …+ Experience in device assembly and/or packaging. + Understanding of basic requirements of regulatory agencies such as the FDA , DEKRA, and OSHA. + Safety ... Description:** Join our elite team at Eli Lilly as we achieve drug product manufacturing and commercialization excellence. As the Associate Director of Technical… more
- Lilly (Indianapolis, IN)
- …teams in new product development activities over the entire spectrum of drug development and clinical trial phases. Specific activities include developing or ... reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at… more
- Lilly (Indianapolis, IN)
- …will also interact with external consultants, opinion leaders, and worldwide regulatory agencies, and will provide oversight for responding to medical and ... regulatory questions and requests related to products. The Sr....with current local and international regulations, laws, guidance (eg FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company… more
- Novo Nordisk (Bloomington, IN)
- …model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized ... Team Novo Nordisk and help us make what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment… more
- United Therapeutics (Indianapolis, IN)
- …+ Maintain deep understanding of external patient related guidance documents including FDA guidance on patient focused drug development (PFDD) and patient ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- Abbott (Westfield, IN)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... 2 years of Software Quality Engineering experience + Detailed knowledge of FDA , GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including statistical/data… more
- Cardinal Health (Indianapolis, IN)
- …daily activities of Chemists or business support staff in the analysis of raw materials, drug substance, in-process and drug product testing. + Is a quality lead ... event is handled in accordance with site SOPs and regulatory requirements + Oversees chemists and contractors who operate...work experience with 21 CFR 210, 211 in the FDA regulated industry preferred (Pharmaceutical or Medical Device). +… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** Act as the primary… more
- Lilly (Indianapolis, IN)
- …compliance with Lilly policies, local and international regulations, laws, guidance (eg FDA , EMA, ICH, etc.), Good Clinical Practices (GCPs) and corporate integrity ... these strategies. + Develop, define, and deliver immunogenicity and biomarker related regulatory submission strategies and documents for Lilly assets. + Develop and… more
- Lilly (IN)
- …consultative support to product teams, internal Lilly partners, external organizations, regulatory agencies and external partners on medical and scientific issues. ... and dose finding studies, as well as authoring of regulatory documents. You will act as a scientific and...current local and international regulations, laws, guidance (for example, FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company… more