- Regeneron Pharmaceuticals (Tarrytown, NY)
- …analyses supporting regulatory submissions and engaging directly with agencies (eg, FDA , EMA, PMDA). + Hands-on experience with a broad range of quantitative and ... join the Quantitative Pharmacology (QP) group. The AD will lead model-informed drug development strategies supporting one or more therapeutic areas across modalities… more
- Mount Sinai Health System (New York, NY)
- …patient care needs, remains cost-effective, and is compliant with applicable regulatory , financial, and accreditation standards. The Buyer works closely with ... of contracts and pricing agreements as well as TPA administration 3. Regulatory & Compliance * Ensures proper purchasing practices and documentation in compliance… more
- Cardinal Health (Albany, NY)
- …GDPR (General Data Protection Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV (Computer System Validation), ... maintains security policies and IT compliance programs in alignment with regulatory , legal, and contractual requirements, while collaborating closely with key… more
- Cytel (Albany, NY)
- …satisfaction objectives. + Build and maintain relationships with senior stakeholders, including regulatory agencies (eg, FDA , EMA), key opinion leaders, and ... Demonstrated leadership in MIDD, Pop-PK/PK-PD modeling, and quantitative strategy within drug development. + Experience interacting with regulatory authorities… more
- BrightSpring Health Services (Albany, NY)
- …+ Knowledge of drug therapy guidelines, medication safety practices, and regulatory standards (CMS, DEA, FDA ). + Proficiency in electronic medical records ... bonuses As a Pharmacist you will: + Evaluate physician medication orders for drug appropriateness, correct dosage, potential drug interactions, and proper route… more
- Pfizer (New York, NY)
- …clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …biotech, or healthcare industry. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... (G&A) functions. This role ensures that learning strategies align with regulatory requirements, corporate standards, and business objectives, fostering a culture of… more
- Excellus BlueCross BlueShield (Rochester, NY)
- …agencies, professional medical associations, the BlueCross BlueShield Association, the Food and Drug Administration ( FDA ), and Centers for Medicare and Medicaid ... and remediating allegations of FWA while adhering to compliance and regulatory requirements. Primary activities include substantiating referrals, case planning and… more
- Sumitomo Pharma (Albany, NY)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Sumitomo Pharma (Albany, NY)
- …submissions. + Participate in all validation activities pertaining to commercial products ( regulatory starting materials, drug substances, and drug ... with multiple therapeutic modalities (eg API, solid dosage, biologics, gene therapies, drug /device combination products) is required. Must be familiar with EMA and … more
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