- 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
- 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
- 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)
- …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
- Wipfli LLP (Radnor, 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 (Radnor, 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
- 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
- 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
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... for IDE and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performing routine maintenance of… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical ... Description Summary With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken… more
- RxBenefits (Philadelphia, PA)
- The Associate Counsel, Regulatory provides substantive support to the Legal Department, working primarily with the Regulatory team to monitor and advise on ... with federal, state, and local agencies. + Respond to regulatory agency inquiries + Providing legal support on various...years of experience in a relevant legal field. + Regulatory experience required. + Demonstrated competence in MS Word,… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory will leverage CMC technical knowledge and ... regulatory science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the delivery of… more
- Penn Medicine (Philadelphia, PA)
- …Jersey, and Delaware. Reporting to the Senior Director of Government Relations and Regulatory Affairs, the Associate Director helps develop and implement Penn ... New Jersey, and Delaware, including tracking, analyzing, and engaging on legislative, regulatory , and policy developments relevant to Penn Medicine. Must have strong… more
- J&J Family of Companies (Horsham, PA)
- …America **Job Description:** We are searching for the best talent for Associate Medical Director, US Medical Affairs -Gastroenterology based in Horsham, PA. **About ... at https://www.jnj.com/innovative-medicine **Purpose:** J&J Innovative Medicine is seeking an Associate Medical Director, US Medical Affairs -Gastroenterology to be… more
