- Wipfli LLP (Philadelphia, PA)
- …in technology enablement initiatives. + Ensure Compliance:Adhere to legal, regulatory , and internal policy requirements. + Support Planning:Assist with annual ... data analysis tools. + Strong understanding of compensation principles and regulatory considerations. + Excellent communication and stakeholder management skills. +… 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
- 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)
- …authoring and review of Investigator Brochures, INDs, briefing books and other regulatory documents, as applicable. The Associate Director, Biopharmaceutics will ... **Job Description** **The Position** The Associate Director, Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of… more
- Merck & Co. (North Wales, PA)
- …(nAMD), and retinal vein occlusion (RVO)).-We are currently recruiting for an Associate Director US Marketing, HCP Strategy - Ophthalmology. This is an exciting ... multiple stakeholders including sales, marketing operations, Learning and Development, Legal, Regulatory , Medical, etc. They will develop and track key performance… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… 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
- Merck & Co. (Upper Gwynedd, PA)
- …pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… 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)
- …developing therapies that make a meaningful difference worldwide. Could you be our next Associate Director, PV Standards and Governance? The job is in our King of ... and quality in safety data management across the R&D organization, supporting regulatory readiness and scientific integrity. **The Role** + Maintain PV data… 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)
- Associate Director, Corporate & External Affairs, R&D Portfolio **Position Purpose:** The Associate Director, Corporate and External Affairs, R&D Portfolio will ... for patients and partners. + Serve as a key partner to regulatory policy team providing strategic counsel on advocacy opportunities, and stakeholder engagement.… 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
- 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
- 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
