- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …all **pharmacometrics** activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. You will conduct analysis , execution and reporting of ... **population PK, PK/PD and modeling and simulation** . + **Provide pharmacometrics analysis ** and participates in activities related to analysis and reporting… more
- PNC (Pittsburgh, PA)
- …strengths and limitations of the model. + Leads in the preparation and analysis of detailed documents for validation and regulatory compliance, using applicable ... combination of python coding skills, deep product understanding, financial reporting and analysis , and machine learning modeling skills. You will also rely on strong… more
- Burns & McDonnell (Conshohocken, PA)
- …by regulatory agencies. + Develops and conducts detailed financial analysis using a variety of computer-based software. + Develops technical reports and ... consulting services to help clients make decisions backed by business and engineering analysis . This role will contribute to the execution of technical studies and… more
- 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)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... driving pipeline impact: population pharmacokinetics (PK) and pharmacodynamics (PD) analysis , model-based meta- analysis (MBMA), clinical trial simulations (CTS),… more
- Merck (Upper Gwynedd, PA)
- …of clinical development, including study design, initiation, execution, monitoring, analysis , regulatory reporting, publication, and presentation at national ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- PNC (Pittsburgh, PA)
- …limitations of the model. + Provides consultative feedback around the preparation and analysis of regulatory compliance documents. PNC Employees take pride in ... combination of python coding skills, deep product understanding, financial reporting and analysis , and machine learning modeling skills. You will also rely on strong… more
- PNC (Pittsburgh, PA)
- …may be performed remotely, at manager's discretion. PNC is seeking a Portfolio Analysis & Strategy Specialist Senior in the Commercial Credit Analytics team within ... of the project scope change control process and procedures. * Perform data analysis and present results to stakeholders, senior leadership and governance forums. *… more
- PNC (Pittsburgh, PA)
- …strengths and limitations of the model. Reviews and approves the preparation and analysis of detailed documents for validation and regulatory compliance. + ... testing frameworks, and compliance with Basel, CCAR, IRRBB and Liquidity Risk regulatory framework. This highly visible role reports directly to the Chief Market… more
- Merck (West Point, PA)
- …in alignment with the company's business goals, and quality and regulatory compliance. **Essential Duties and Responsibilities:** + Utilize extensive experience in ... in both development and lifecycle management, ensuring compliance with relevant regulatory standards. + Ensure robust technical plans, risk communication, drive… more