- Merck (West Point, PA)
- …transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group ... process demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC sections of filing.… more
- Merck (West Point, PA)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. Under the general scientific and administrative direction ... next generation process development and characterization, process validation, and regulatory submission authoring. **In this role, the successful candidate will… more
- Merck (West Point, PA)
- …oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more
- Merck (West Point, PA)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... and interpretation of data. + Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and… more
- Penn Medicine (Philadelphia, PA)
- …Focus energy on collaboration and not blame Support Established Workflow and Regulatory Documentation: Building work practices and team processes compliant with ... regulatory requirements and program goals and initiatives Ensures adequate...of the program(s) and the institute **Credentials:** Registered Nursing License - PA (Required) Education or Equivalent Experience: Bachelors… more
- Merck (West Point, PA)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more
- Duquesne Light Company (Pittsburgh, PA)
- …Corporation (NERC) Operations & Planning Reliability Standards, the Engineer - Regulatory Compliance Associate IV will assist in the coordination and execution ... of regulatory compliance activities for the Company. This includes supporting...of 5 years of experience, a professional engineering (PE) license plus 3 years of experience working in Transmission… more
- Geisinger (Lewistown, PA)
- …4:00 pm. A Master's Degree in Nursing (MSN) and a Pennsylvania Registered Nurse license is required. A minimum of 5 years healthcare experience is also required. Job ... policies, and procedures of the controlling institution and all applicable regulatory and accreditation agencies. + Interpret and apply administrative policies in… more
- Penn Medicine (Lancaster, PA)
- …based on clinical judgments and/or triage protocols in accordance with regulatory requirements and standards of practice. Consults with provider as necessary. ... by the provider and in accordance with department protocol, regulatory requirements and standards of practice. + Prepares and...+ May require some regional travel - valid driver's license is required if traveling. + Participates in the… more
- Cardinal Health (Harrisburg, PA)
- …to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company ... (GPOs, IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory /compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong business… more