- GRAIL (Harrisburg, PA)
- …clinical affairs, quality, or program management within the IVD, medical device, or pharmaceutical industries is required. + Regulatory affairs and IVD device ... Regulatory Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical, statistical, or regulatory settings-especially in oncology,… more
- CSL Behring (King Of Prussia, PA)
- …developing therapies that make a meaningful difference worldwide. The Senior Director , Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic ... plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development… more
- CSL Behring (King Of Prussia, PA)
- …to developing therapies that make a meaningful difference worldwide. The Associate Director Clinical Operations Lead is accountable for the development of the ... and may take on additional responsibilities as defined by the Senior Director Clinops Program Lead. **Main Responsibilities:** + Clinical Operations Strategy: Design… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Director , Epidemiology? This position is located in our King of Prussia PA or Waltham ... generation, vendor management. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports. - Contribute… more
- CSL Behring (King Of Prussia, PA)
- …committed to developing therapies that make a meaningful difference worldwide. The ** Director Clinical Operations Lead** is accountable for the development of the ... collaboration among internal and external stakeholders (including vendors, investigators, and regulatory authorities). Act as the primary point of contact for all… more
- CSL Behring (King Of Prussia, PA)
- …biotech/ pharmaceutical experience. **Experience** + Strong knowledge of the regulatory requirements for MDRP, Medicare/IRA, Veteran's Healthcare Act, and other ... collection and submit all reports needed for compliance. 4. Work with Senior Director , Policy Advocacy & Government Affairs, & Legal to interpret and implement… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …. **Job Description** This role reports directly to the Executive Director , Clinical Operations and collaborates closely with the leadership of Clinical ... oversight of the vendor(s). + Establish and oversee activities to ensure regulatory compliance across all project teams by establishing clinical research best… more
- CSL Behring (King Of Prussia, PA)
- …preferred. + - Clinical development industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential. + - 3+ ... a meaningful difference worldwide. Could you be our next Director of Clinical Program, Immunoglobulins ? The job is...Study Reports (CSR). + the clinical sections of relevant regulatory packages (eg IND, NDA, annual reports) and support… more
- CSL Behring (King Of Prussia, PA)
- The Opportunity: + Reporting to the Senior Director of Global Forecasting & Portfolio Analytics, you will lead the BD&L forecasting and Analytics for Cardiovascular ... will play a pivotal role in shaping our strategic direction and optimizing our pharmaceutical portfolio. The Role: + Lead end to end forecasting & analytics efforts… more
- Parexel (Harrisburg, PA)
- …transform scientific discoveries into new treatments. From clinical trials to regulatory , consulting, and market access, our therapeutic, technical, and functional ... First, Quality, Respect, Empowerment & Accountability. **Parexel is looking for a Medical Director with a very strong background in Ophthalmology to join our Global… more
