- Eisai, Inc (Philadelphia, PA)
- …budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with ... difference. If this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading, managing,… more
- Merck & Co. (Montgomery County, PA)
- …described in the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), ... 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)
- …degeneration (nAMD), and retinal vein occlusion (RVO)).-We are currently recruiting for an Associate Director US Marketing, HCP Strategy - Ophthalmology. This is ... Job DescriptionAssociate Director US Marketing, HCP Strategy - OphthalmologyOur company...stakeholders including sales, marketing operations, Learning and Development, Legal, Regulatory , Medical, etc. They will develop and track key… 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
- 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...project workflows in core markets. + Support the Executive Director with internal audits, regulatory inspections and… 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 ... Director of Medical Affairs Outcomes Research. Core elements enabling...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)
- …INDs, briefing books and other regulatory documents, as applicable. The Associate Director , Biopharmaceutics will be the primary author for module 2.7.1 ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert...responsible for contributing to and reviewing clinical modules for regulatory submissions, contribute the authoring and review of Investigator… more
- Organon & Co. (Plymouth Meeting, PA)
- …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 products in… 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
- Organon & Co. (Plymouth Meeting, PA)
- …**The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing and?implementing ... in accordance with global regulations and?guidance, and?Organon procedures.? The Associate Principal Scientist will lead the?preparation and submission of CMC… 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 ... 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)
- …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)
- **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 (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)
- 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
- 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
- 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
- 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
