- J&J Family of Companies (Spring House, PA)
- …project teams as well as functional area partners in Discovery, Late Development, Regulatory Affairs , Epidemiology, Market Access, Medical Affairs and other ... you? If it is, you will report to the Senior Director, R&D Data Science and Digital Health, Immunology...and may lead cross-functional teams for evaluation of new scientific opportunities, disease areas, product ideas, implement franchise business… more
- ICON Clinical Research (Blue Bell, PA)
- …direction and decision-making processes, and offer expert medical and scientific guidance, leveraging therapeutic expertise to inform project development. **What ... and guidance on project teams. + Offering expert medical and scientific consultation throughout project lifecycles. + Ensuring compliance with ethical, legal,… more
- J&J Family of Companies (Spring House, PA)
- …radiomics, etc. across R&D and early and late-stage clinical development, ensuring scientific rigor and regulatory compliance. + Collaborate with internal ... biomarker discovery, translational research, computer vision, clinical development, medical affairs , diagnostics, regulatory , and commercial teams to assess… more
- Sanofi Group (Swiftwater, PA)
- …Background in manufacturing and development, Quality Assurance, Quality Control, and Regulatory Affairs . + Competencies (LEAD model) - key competencies ... are distributed throughout the world. This position guarantees the Quality and Regulatory compliance of products developed, manufactured and distributed by the site… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Merck (West Point, PA)
- …biologics and vaccines. The role also requires extensive engagement with Manufacturing, QA, Regulatory Affairs , and Supply Chain. The ideal candidate should have ... for the program will report to this position. + Ensure GMP/GLP and global regulatory compliance; prepare for and respond to inspections. + Define and execute BCR… more
- Merck (Upper Gwynedd, PA)
- …strategic and tactical input from diverse disciplines (eg, Medical Affairs , Outcomes Research, Market Access, Biostatistics and Research Decision Sciences, ... they need. * Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common projects. Sharing lessons learned… more
- Sanofi Group (Swiftwater, PA)
- …Participating in internal and external audits and inspections + Collaborating with regulatory affairs to ensure compliance with local and international ... + Overseeing the batch release process to ensure compliance with regulatory requirements and company standards + Overseeing review and approval of… more
- CSL Behring (King Of Prussia, PA)
- …business solutions. In this role you will be reporting in to the Senior Director of Commercial Business Analytics Reporting & Data Science. Lead development and ... Medical and Tender use cases) In close partnership with ABCIA Commercial, Medical Affairs , and Market Access teams to ensure solutions are aligned with strategic… more
- CSL Behring (King Of Prussia, PA)
- …required data collection and submit all reports needed for compliance. 4. Work with Senior Director, Policy Advocacy & Government Affairs , & Legal to interpret ... of biotech/pharmaceutical experience. **Experience** + Strong knowledge of the regulatory requirements for MDRP, Medicare/IRA, Veteran's Healthcare Act, and other… more