- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …and clinical systems including National Fire Protection Association (NFPA), Food and Drug Administration ( FDA ), Nuclear Regulatory Commission (NRC), the ... position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to...Ensure compliance with all applicable standards, policies, procedures, and regulatory requirements such as NFPA, FDA , NRC,… more
- Wolters Kluwer (Philadelphia, PA)
- …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
- Merck (West Point, PA)
- **Job Description** **Join Our Team as a Biologics Drug Substance Commercialization Leader!** Are you ready to take your career to the next level? We are seeking a ... and commercialization projects. **Why You'll Love This Role:** As a Biologics Drug Substance commercialization Leader, you'll be at the forefront of scientific… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …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
- PCI Pharma Services (Philadelphia, PA)
- …Manager is responsible for the safety, quality, and operational excellence for Advanced Drug Delivery value stream. In this role they provide leadership to the ... procedures, along with all federal, state and local regulations, including OSHA, FDA , cGMP standards and employment law + Demonstrate substantial knowledge of the… more
- Guthrie (Sayre, PA)
- …+ Minimum 3-5 years of direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH, or HHS. + Minimum 5 ... + Advises The Guthrie Clinic senior leadership on HRPP regulatory issues. + Oversee FDA inspections, audits,...scientific review, funding and resource allocation. Communicate directly with FDA for investigational new drug (IND) and… more
- Sumitomo Pharma (Harrisburg, PA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Provide clinical and medical expertise across all stages of drug development, from preclinical transition to post-marketing. + Stay... Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions,… more
- Merck (West Point, PA)
- …and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek ... performance testing. + ** Regulatory Compliance** : + Strong knowledge of relevant regulatory requirements such as ISO, USP, FDA guidelines, and other global … more
- Primo Brands (Ephrata, PA)
- …to ensure regulatory compliance with the applicable Food and Drug Administration ( FDA ), State, Local, International Bottled Water Association (IBWA), ... and maintain manufacturing plant quality assurance programs to ensure adherence to established FDA , State, local, IBWA and PWNA standards. + Contribute as a member… more
- West Pharmaceutical Services (Exton, PA)
- …and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer system ... global quality and lab requirements. + Provide expertise and guidance for regulatory and industry expectations in terms of data integrity requirements: computer… more