- Merck (North Wales, PA)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...to Executive Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy… more
- J&J Family of Companies (Horsham, PA)
- …compounds and compounds in clinical development within the Immunology TA. The GMAL will lead the Global Medical Affairs Team and partner closely with ... areas. Be an active member of the CDT and lead a Global Medical Affairs ...Excellent knowledge of study execution, benefit risk management and regulatory affairs . + Proven ability to act… more
- J&J Family of Companies (Horsham, PA)
- …skills and the ability to influence is necessary * Experience interacting with global regulatory authorities is also desirable * Approximately 20% travel ... portfolio of IMM products. She/he will partner with colleagues from Commercial, R&D, Global Medical Affairs , Real-world Value & Evidence, Biostatistics, and work… more
- Bristol Myers Squibb (Trenton, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy within a development team (DT). ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...PharmD, MS, or BS **Experience Requirements** Significant experience in regulatory affairs (eg > 4-7 years) **Key… more
- University of Pennsylvania (Philadelphia, PA)
- …and ensure optimal communication across stakeholders. Responsibilities will also include providing regulatory support and oversight for the global and newly ... and resources, and much more. Posted Job Title Associate Director, Student Affairs , Graduate Programs (Department of Radiation Oncology) Job Profile Title Associate… more
- Bristol Myers Squibb (Trenton, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements**… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory ... Project Management and be a part of the Global Regulatory Affairs Team. **How...and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-… more
- Organon & Co. (Plymouth Meeting, PA)
- …products through the product lifecycle. + Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of ... CMC changes, identification of global regulatory requirements, and critical evaluation of...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- J&J Family of Companies (Spring House, PA)
- …tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Global Regulatory Affairs business technology team is focused on ... leading-edge technology solutions to help drive J&J Innovative Medicine's Global Regulatory Affairs organization, we...lead role in the development of a Unified Regulatory Platform (URP) and will lead technical… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Trenton, NJ)
- … requirements. You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling ... issues to Global Labeling management and the Global Regulatory Lead + Recommend...+ Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts… more
- Bristol Myers Squibb (Trenton, NJ)
- …Lead is accountable for medical leadership, strategy and execution of medical affairs -related activities for Eliquis within the broad global Eliquis Alliance ... will have accountability to act as the WW Medical Lead for Eliquis reporting to the Executive Director, WW...(eg Development, R&D, HEOR, Value Access & Pricing, MEG Regulatory , Commercial, Corporate Affairs , etc.) on key… more
- J&J Family of Companies (Horsham, PA)
- …experience. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance) including at ... Associate Director, Global Labeling Product Leader - 2406187352W **Description** Johnson...a positive impact on their communities. **Key Responsibilities:** + Lead the development, revision, review, agreement, and maintenance of… more
- J&J Family of Companies (Titusville, NJ)
- …, Directors of Marketing (DOM) and other cross-functional Key Stakeholders (KSH) within NS Global MAF, Regulatory , JSA (Scientific Affairs ) and R&D. * Has ... is recruiting for a Head, Neuroscience Medical Franchise within the US Medical Affairs Neuroscience organization located in Titusville, NJ. At Johnson & Johnson, we… more
- Organon & Co. (Plymouth Meeting, PA)
- …Officer, working directly with the US Federal and State Policy and Government Affairs teams, the Global Policy team, the US Commercial organization, Organon ... cross-functional projects that are relevant to the US Government Affairs team and beyond. The Director will lead...to draft formal comments related to federal and state regulatory action. Develop public policy positions and cover policy… more
- Bristol Myers Squibb (Trenton, NJ)
- …+ Clinical Research & Development + Biostatistics + Translational Development + Regulatory Affairs + Project Leadership + External: + Investigators, ... but are not limited to, the following: 1. Leadership responsibilities: + Represent Global Medical Affairs in cross functional teams/meetings, eg GPT + Work… more
- Merck (North Wales, PA)
- …IEP) is a role within Global Medical and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director, ... regulatory guidelines and compliance requirements pertaining to Medical Affairs operations, and, preferably, experience in navigating regulatory challenges… more
- J&J Family of Companies (Horsham, PA)
- …**Required Technical Knowledge and Skills:** + Ability to effectively and strategically lead global cross-functional teams + Connect, collaborate and build ... for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as the product spokesperson regarding...(HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the MSO will also lead … more
- Organon & Co. (Plymouth Meeting, PA)
- …aiming to efficiently generate evidence that allows internal decision making, supports global registration with regulatory agencies and other health authorities, ... and is accountable for: + The leadership of the following teams: Global Clinical Development (GCD), Clinical Trial Operations (CTO), Clinical Data Sciences (CDS)… more
- Sumitomo Pharma (Trenton, NJ)
- …impacting business decisions. + Proficient in GMP manufacturing, quality assurance, regulatory affairs , and clinical operations. + Demonstrated ability to ... active pharmaceutical ingredients, drug products, and finished goods. + Lead and or enable new global product...of all products. + Identify risks (business, performance, quality, regulatory , external, etc.) to ensure supply and work with… more