- Parexel (Trenton, NJ)
- … requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate , you will serve as the primary regulatory ... Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are...to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their… more
- 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
- 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 provide ... 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 team. ... 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
- Integra LifeSciences (Trenton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The ** Associate Manager, Medical Writing** is a senior level professional with advanced knowledge ... + Prepares complex clinical deliverables in accordance with internal GSOPs, and regulatory guidelines including clinical sections for regulatory documentation as… more
- CSL Behring (King Of Prussia, PA)
- **Job Title:** Associate Director, Strategic Forecasting and Portfolio Analytics **Reporting to:** Director, Strategic Forecasting & Portfolio Analytics **Position ... scenario modeling; forecast submission - Stay updated on industry trends, regulatory changes, and advancements in forecasting methodologies within the biotech and… 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 will ... decisions + A deep understanding of the pharmaceutical industry, including regulatory requirements, market dynamics, and emerging AI technologies, with the foresight… more
- CSL Behring (King Of Prussia, PA)
- …trackers, SOPs, and governance frameworks that ensure scientific integrity and regulatory compliance. You will also drive innovation in publication metrics and ... digital engagement, helping us measure and enhance our scientific impact globally. As a more senior member of the publications team, you will also be expected to provide strategic and operational mentorship to less experienced colleagues. **RESPONSIBILITIES… more
- CSL Behring (King Of Prussia, PA)
- …of biotech/pharmaceutical experience. **Experience** + Strong knowledge of the regulatory requirements for MDRP, Medicare/IRA, Veteran's Healthcare Act, and other ... Federal regulations mandating price and/or transparency disclosures. + Experience with implementation and utilization of financial & pricing systems. Model N preferred. + Strong Excel skills as well as MS Office proficiency Demonstrated ability to function… more
- Parexel (Trenton, NJ)
- …for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at ... 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 timely and… more
- Parexel (Trenton, NJ)
- The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local ... 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 timely and… 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 ... command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical… more
- ABBTECH Professional Resources, Inc. (Trenton, NJ)
- **Financial Project Associate ** **Exempt** Embark on a dynamic career with Premier Group Services, Inc., a leading CPA Management and Consulting firm dedicated to ... approach that ensures responsiveness and lasting relationships. **Join as a Project Associate ** As a Project associate at Premier Group Services, Inc.,… more
- Parexel (Trenton, NJ)
- …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 closely with...including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and… more
- Towne Park (Plymouth Meeting, PA)
- …best practices for data integrity, system security, and compliance with regulatory requirements. + Lead projects related to system upgrades, enhancements, and ... _described here are representative of those that must be met by an associate to_ **_successfully perform the essential functions of this job_** _. Reasonable… more
- CSL Behring (King Of Prussia, PA)
- …processes and driving operational excellence. This position reports to the Associate Director, Contract Execution and works closely with internal stakeholders to ... strategic alignment across the organization. Reporting Relationships + Reports to: Associate Director, Contract Execution + Direct Reports: None Key Responsibilities… 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 is located ... with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory , Process Development groups and MST counter parts located in… more
- Wipfli LLP (Philadelphia, PA)
- …quarterly and annual close processes and preparation of quarterly lender and regulatory reporting. + Review and approve complex journal entries and reconciliations ... location, skills, experience, training/education, licensure, certifications, business needs, current associate pay, and relevant employment laws. Individuals may be… more
- Parexel (Trenton, NJ)
- …readiness for First Subject First Visit (FSFV) + Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV + ... with CRA for enrollment delivery during study conduct + Partners with local Regulatory authorities and Study Start up teams to ensure timely completion on country… more
