- GRAIL (Trenton, NJ)
- …For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal ... including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements,… more
- Parexel (Trenton, NJ)
- …success, we are expanding our esteemed Medical Sciences Team and seeking an Associate /Medical Director to support the growth of our Global Immunology and ... Inflammation Therapeutic Franchise. As an Associate / Medical Director , you will work...including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** We are looking for an experienced Associate Director , Program Manager to join our team. This successful candidate will ... in R&D functions (eg, Clinical Research, Early Development, Medical Affairs, Pharmacovigilance, Regulatory Affairs, etc.) + At least three years of experience in… more
- CSL Behring (King Of Prussia, PA)
- …therapies that make a meaningful difference worldwide. We are looking for a ** Associate Director ,** **Case Management Intake & Submissions** to join our R&D ... monitor successful reporting and resolve submission failures to minimize impact to regulatory compliance. The Case Submission aspect of the function has a high… more
- CSL Behring (King Of Prussia, PA)
- The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical ... strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables...study design and data analysis for clinical trials and regulatory submissions + Influence and contribute to clinical development… more
- CSL Behring (King Of Prussia, PA)
- **Job Title:** Associate Director , Strategic Forecasting and Portfolio Analytics **Reporting to:** Director , Strategic Forecasting & Portfolio Analytics ... **Position Description Summary:** . Reporting to the Director of Strategic Forecasting & Portfolio Analytics, you will lead forecasting programs centered around… more
- CSL Behring (King Of Prussia, PA)
- The Associate Director , Commercial Data Science & AI is crucial in driving the overall strategy for (Gen)AI tools and technologies within CSL. This individual ... solutions. In this role you will be reporting in to the Senior Director of Commercial Business Analytics Reporting & Data Science. Lead development and deployment… more
- CSL Behring (King Of Prussia, PA)
- …collaboration across the enterprise. Under the guidance of the Publications Director , you will partner with Medical Affairs leaders, Compliance, Clinical, HEOR, ... trackers, SOPs, and governance frameworks that ensure scientific integrity and regulatory compliance. You will also drive innovation in publication metrics and… more
- CSL Behring (King Of Prussia, PA)
- …collection and submit all reports needed for compliance. 4. Work with Senior Director , Policy Advocacy & Government Affairs, & Legal to interpret and implement ... of biotech/pharmaceutical experience. **Experience** + Strong knowledge of the regulatory requirements for MDRP, Medicare/IRA, Veteran's Healthcare Act, and other… more
- Parexel (Trenton, NJ)
- …works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a ... and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents… more
- Parexel (Trenton, NJ)
- …works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a ... and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents… more
- Parexel (Trenton, NJ)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site… more
- BeOne Medicines (Pennington, NJ)
- …and authoring of various reports. This position reports directly into the Associate Director , Manufacturing Science and Technology (MST) Cell Culture and ... with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory , Process Development groups and MST counter parts located in… more
- Parexel (Trenton, NJ)
- …of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director , and Project Director . To excel in this role, ... flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational… more
- CSL Behring (King Of Prussia, PA)
- …contract processes and driving operational excellence. This position reports to the Associate Director , Contract Execution and works closely with internal ... ensure strategic alignment across the organization. Reporting Relationships + Reports to: Associate Director , Contract Execution + Direct Reports: None Key… more
- BeOne Medicines (Pennington, NJ)
- …company standards. This role is based in Hopewell, NJ and reports to the Associate Director , Utilities and Facility. **Essential Functions of the Job:** + Meet ... are in place. Develop and maintain engineering processes and procedures aligned with regulatory and quality standards. Ensure compliance with NFPA, NEC, OSHA, and… more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity:** Reporting to the Associate Director , Business Operations Management, as the **Manager, Clinical Financial Modeling** , you will be presented ... delivered based on the requirements of the PST strategy, appropriate international regulatory standards, and within the agreed timeframe and budget. + Collaborate… more
- University of Pennsylvania (Philadelphia, PA)
- …wealth of health and wellness programs and resources, and much more. Posted Job Title Associate Director , Regulatory Job Profile Title Associate ... Job Description Summary With the oversight of the Director , the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She...the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to ... interpret the impact of regulatory changes to the pharmaceutical environment. **Job Description** +...+ Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated regulations… more
