- Cardinal Health (Indianapolis, IN)
- …with investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- Cardinal Health (Indianapolis, IN)
- …False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), and privacy (HIPAA). ... to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all 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 ... and automation, packaging, capital projects, while maintaining compliance with regulatory standards. Process Engineering focuses on developing processes to minimize… more
- Cytel (Indianapolis, IN)
- …motivate a strong team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development ... in related areas (adaptive designs, clinical development, data science, model-informed drug development), to provide strategic advice to define optimal regulatory… 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 ... and automation, packaging, capital projects, while maintaining compliance with regulatory standards. Process Engineering focuses on developing processes to minimize… 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 ... and automation, packaging, capital projects, while maintaining compliance with regulatory standards. Process Engineering focuses on developing processes to minimize… more
- Lilly (Indianapolis, IN)
- …and/or program + Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA , ICH, GCP, PhRMA, ... Plan, database, and observed datasets) + Support submission, inspection and regulatory response activities + Lead cross Business Unit/Therapeutic Area projects or… more
- Lilly (Indianapolis, IN)
- … discovery and development process. + Strong problem-solving skills. + Experience with regulatory guidelines and standards (eg, GLP, FDA , EMA). Lilly is ... analyze, and interpret toxicological data, ensuring accuracy and compliance with regulatory standards. + Prepare and present project findings, updates, and reports,… 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, including operational protocol development, to implement compliance with FDA GMP requirements + Draft SOPs for building operation, maintenance,… more
- Lilly (Lebanon, IN)
- …**Startup Phase:** + Ensure utility operations maintains compliance with all regulatory requirements at all times + Ensure utility areas appropriately support ... and they are maintainedin accordance with local and corporate regulatory requirements + Understand Health, Safety & Environmental-regulatedenvironment and… more