- Merck & Co. (North Wales, PA)
- …SimBiology, MATLAB, Nonlinear Mixed Effects Modeling (NONMEM), NONMEM, Oncology, Pharmaceutical Development, PKPD Modeling, Programming Languages, Regulatory ... of disease mechanisms and modalities Framing critical questions and strategy for optimizing model-based analyses on programs. Maintaining a comprehensive… more
- Merck & Co. (Lower Gwynedd, PA)
- …Assays, Innovation, Mentoring Staff, Modeling Simulations, Molecular Biology, Pharmaceutical Analysis, Pharmacokinetics, Regulatory Compliance, Results-Oriented ... delivering high-quality data, and helping teams develop a clinical assay strategy for data-driven decision-making. A record of accomplishment of successful… more
- Merck & Co. (Lower Gwynedd, PA)
- …Communication Technology (ICT), Maintenance Management, Management Process, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory ... Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development {+ 4… more
- Eisai, Inc (Exton, PA)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... SOPs, along with providing supporting documentation. They formulate the overall strategy for Upstream and Downstream Operations and will collaborate effectively with… more
- Merck & Co. (North Wales, PA)
- …are seeking a skilled privacy professional to help drive our privacy strategy , implement our global privacy program, ensure compliance with global data protection ... supporting privacy compliance through the development and maintenance of program strategy , processes, tools, and assurance. -The primary responsibility of the Deputy… more
- Merck & Co. (North Wales, PA)
- …and unplanned statistical analyses.Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and ... data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes; and ability to efficiently manipulate very large databases… more
- IQVIA (Wayne, PA)
- …growth. **Role & Responsibilities** The Head of the Center of Excellence (CoE) for Regulatory Strategy sits within the COA consulting business of PCS and plays ... environment + Experience of medical writing for various audiences, including pharmaceutical companies, healthcare professionals, regulatory bodies and patients +… more
- Guidehouse (Philadelphia, PA)
- …Market Access team focuses on value, access, pricing and commercialization strategy projects for pharmaceutical , biotechnology, medical device, and diagnostics ... experience, with demonstrated experience in value, access, pricing and commercialization strategy projects for pharmaceutical , biotechnology, medical device, and… more
- Cardinal Health (Harrisburg, PA)
- …who provide consulting services in a myriad of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry ... Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance + Product Lifecycle Management +… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + 7-years CMC regulatory experience in the pharmaceutical industry with a history of… more
