- Eisai, Inc (Philadelphia, PA)
- …vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads ... If this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading, managing, strategizing,… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing ... in accordance with global regulations and?guidance, and?Organon procedures.? The Associate Principal Scientist will lead the?preparation and submission of CMC… more
- Merck & Co. (Montgomery County, PA)
- …in the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Merck & Co. (North Wales, PA)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems...industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems… 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)
- …**The Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal ... Scientist is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological… 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
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **Position Overview** The Associate Director is responsible for ensuring that Primary Market Research, Competitive Intelligence, and Data ... and procedures, and governing body rules and standards. The Associate Director will: + Be a champion for ethical...our business. + Maintain a vigilant watch over the regulatory environment specific to Primary Market Research and Data… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The role of Associate Director, Dermatology Outcomes Research Epidemiology and Economics will report to the headquarters ... priorities. Developing and implementing patient-centered endpoints strategies, working with regulatory , Value Strategy Assessment (VSA's) and contracting. The role… 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)
- 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)
- 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 ... 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
- 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)
- **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
