- Merck & Co. (Upper Gwynedd, PA)
- …long-standing or significant issues affecting quality and efficiency.Interprets complex regulatory requirements for various audiences, reviews draft policies and ... Management, Quality Oversight, Quality Risk Management, Quality Systems Compliance, Regulatory Compliance {+ 4 more}-Preferred Skills:Job Posting End Date:07/25/2025… more
- Merck & Co. (Upper Gwynedd, PA)
- …of cross functional teams compromised of Global Supply Chain, Global Regulatory Affairs, Labeling, Material Master Data, Finance, Quality, Transfer Team, Transfer ... processes, product physical & financial flows, and awareness of regulatory , quality, and technical processes/ requirements.Primary activities include, but are… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and… 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 ... dataProduce tables and graphics for inclusion in study reports and regulatory submissionsEnsure programmatic traceability from data source to modeling resultSupport… more
- Merck & Co. (North Wales, PA)
- …reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In ... collaboration with internal teams and external partners, design studies, author study protocols, develop measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and publications.Responsible for… 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
- Merck & Co. (North Wales, PA)
- …that help people around the globe. We are currently recruiting for Associate Director, US MarketingThe role will oversee foundational strategy and planning, ... drive and align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc.Our US marketing team has adopted an Agile operating model… more
- Merck & Co. (North Wales, PA)
- …and unplanned statistical analyses.Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and ... associated documentation.Ensure programmatic traceability from data source to analysis/modeling result.Maintain and manage a project plan including resource forecasting.Support the development of programming standards to enable efficient and high-quality… 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 benefit of patients and global human health.The Associate Vice President (AVP), Late Development Statistics, BARDS, is responsible and accountable for the… 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
- J&J Family of Companies (Spring House, PA)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, North America Regulatory Leader. This position is ... your application. We invite candidates from any location to apply. The Associate Director, Regulatory Leader in Global Regulatory Affairs will be responsible… more
- Lilly (Philadelphia, PA)
- …through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the preparation and delivery of high-quality CMC ... regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed...for the generation and execution of country specific CMC regulatory strategies + Author and review global CMC dossiers… more
- J&J Family of Companies (Spring House, PA)
- …of inspection readiness through internal audits and by assuring compliance with regulatory and Johnson & Johnson requirements. The associate ensures compliance ... of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance (QA) Associate II at the Spring House, PA campus! At Johnson & Johnson, we believe… more
- GE HealthCare (Philadelphia, PA)
- …Services, Environment Health and Safety requirements, and/or all other applicable regulatory requirements. **Qualifications :** + Associate 's or Bachelor's ... Environment Health and Safety requirements, and/or all other applicable regulatory requirements. **Job Description** **Roles and Responsibilities:** Role Summary :… more
- Grifols Shared Services North America, Inc (Philadelphia, PA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...an equivalency could include 8 years of experience, an Associate 's degree with 6 years of experience, or a… more
- Penn Medicine (Philadelphia, PA)
- …Officer inclusive of their direct reports (CQO, PSO, Directors - Patient Safety, Regulatory and APP) by providing customer service, assisting in meeting or exceeding ... experience, prior experience supporting leadership all levels project coordination + Associate of Arts or Science in Healthcare Administration or related business… more
- University of Pennsylvania (Philadelphia, PA)
- …and wellness programs and resources, and much more. Posted Job Title Assistant/ Associate Director, Grant and Contract Financial Administration Job Profile Title ... Associate Director D, Business and Finance, Research Services Job...stakeholders, research administrators, internal and external partners, sponsors, and regulatory agencies throughout the post award lifespan of a… more
- Penn Medicine (Philadelphia, PA)
- …is looking for a Clinical Systems Analyst at the Senior, Mid, or Associate level to join the **device integration team.** **Senior Clinical Systems Analyst:** The ... as needed to address complex technical issues maintaining compliance with regulatory standards such as HIPAA. Understands integration between various applications… more
- Merck (West Point, PA)
- …in West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our robust infectious disease and vaccines pipeline. As an ... Associate Director, you will represent QP2 on cross-functional teams...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
