- Merck (West Point, PA)
- …GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or ... in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related… more
- Pfizer (Collegeville, PA)
- …+ Drives team process for preparation of governance presentations. **Program Risk Analysis and Management** + Leads the team in the preparation, implementation, ... development committee. **Submissions** + Provides comprehensive project management for regulatory submission activities for initial market authorizations in major… more
- Merck (West Point, PA)
- …engagements. This includes the ability to: + Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH) + Ability to manage multiple competing ... clinical drug development, project management, and/or medical field experience OR PhD /PharmD Degree in life sciences, preferred. **Ideal candidate would have:** +… more
- J&J Family of Companies (Malvern, PA)
- …sites, analytical control strategy, justification of specifications, and criticality analysis . **Qualifications / Requirements:** **Education:** + PhD in ... for working with teams in the preparation of technical documents and regulatory submissions, participating in review, and contributing to development of strategies… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …upstream process technology transfers to CDMOs, including documentation review, gap analysis , and risk assessment. + Provide expert technical oversight of upstream ... and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. +… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification ... + Lead complex manufacturing investigations and deviations, ensuring thorough root cause analysis and effective CAPA implementation at CDMOs. + Drive strategies for… more
- UNUM (Harrisburg, PA)
- …Medicine and Rehabilitation. This position is responsible for providing expert medical analysis of claims files (or underwriting applications) across Unum US product ... services to the Benefits Center. The Medical Consultant adheres to current regulatory , claim process, and internal workflow standards as set forth in the… more
- PNC (Pittsburgh, PA)
- …boundaries without having direct management authority. * Ability to provide analysis on problem trends and identify process improvement opportunities for continuous ... to support product strategies and revenue generation/cost reduction. + Manages the analysis & elicitation of complex client requirements, and the transformation of… more
- PNC (Pittsburgh, PA)
- …landscape continuously to identify risks and opportunities. Oversees ad hoc pricing analysis and reporting. + Manages rate exception process and strategy and ... to be successful in this position. **Preferred Skills** Budget Analysis , Budget Management, Competitive Advantages, Data Analytics, Enterprise Resource Planning… more
- PNC (Philadelphia, PA)
- …align product and payments industry vision with research and qualitative and quantitative analysis of client data, market trends and competitive analysis and ... change and transformation * Ability to performs ongoing competitive analysis of payment product solutions * Experience in creating...Higher level education such as a Masters degree, or PhD is desirable. Industry experience is typically 8 +… more