- Lilly (Philadelphia, PA)
- …of approved suppliers, products, and components + Review technical and regulatory documentation to ensure accuracy, consistency, and currency of all critical ... senior leadership, when required. + Assume additional responsibilities supporting the broader CMC Development group, as needed. **Basic Requirements:** + BS or MS… more
- Lilly (Philadelphia, PA)
- …and ensure retest and expirations dates can support clinical development and regulatory objectives & timelines + Maintain oversight of precursor and reference ... development, validation and stability reports and analytical sections in global regulatory dossiers and support responses to information requests from health… more
- Teva Pharmaceuticals (West Chester, PA)
- …and over-the-counter therapies with scientific rigor and innovative thinking. Biologics CMC , a critical division within Teva Pharmaceuticals, focuses on the ... filing. The Drug Product Development (DPD) group, situated within Biologics CMC , is responsible for formulation development, drug product manufacturing processes,… more
- Merck (West Point, PA)
- …oversee analytical investigations with a strong focus on quality and regulatory compliance. + Excel in impurity isolation, unknown peak identification, ... collaboration. + Maintain a deep understanding of the regional regulatory and business environment, including: + API and Drug...CMOs and CROs. + Have a working knowledge of CMC filing requirements. + Demonstrate strong verbal as well… more
- J&J Family of Companies (Spring House, PA)
- …by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to support clinical ... (L&A) opportunities. + Collaborate proactively with Chemistry, Manufacturing and Controls ( CMC ) functions to assure drug substance quality. + Actively participate in… more
- Teva Pharmaceuticals (West Chester, PA)
- …generics and over-the-counter therapies. The Associate Director at Bioassay Department of Biologics CMC leads a team of professionals to develop and execute plans on ... assays. This role requires close collaboration with cross-functional teams to support regulatory submissions. This role reports to the head (Senior Director) of… more
- J&J Family of Companies (Spring House, PA)
- …to clinical safety issues. + Provide input to product specific regulatory documents for marketed compounds (Development Safety Update Reports, Periodic Benefit ... providing expert toxicological guidance to preclinical and chemistry and manufacturing control ( CMC ) teams pertaining to nonactive substance safety. + Serve as a… more
- UPMC (Pittsburgh, PA)
- …efficiency in claims processing, data collection, and quality reporting. . ** Regulatory Compliance:** Conduct audits on various compliance topics to evaluate ... actions to key stakeholders. . **Leadership Advising:** Advise leadership on regulatory requirements for coding documentation and billing to ensure services are… more
- UPMC (Pittsburgh, PA)
- …billing rules set forth by CMS and other relevant federal and state regulatory agencies. + **E/M and External Audits:** Complete Evaluation and Management (E/M) ... accuracy and compliance of our healthcare services, ensuring we meet all regulatory standards. + **Professional Growth:** Gain valuable experience in auditing and… more
- Merck (West Point, PA)
- …vaccines. This role involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging as well as ... specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals. Individuals in this role will… more