- 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). ... + Serve as team lead or co- lead of marketing application submission...+ Ensure global development plans will meet global regulatory requirements by soliciting and integrating… more
- Novo Nordisk (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … more
- J&J Family of Companies (Titusville, NJ)
- Senior Director , Global Regulatory Leader, CAR-T Therapy - 2406186120W **Description** Johnson & Johnson is currently seeking a Senior Director , ... have a positive impact on their communities. The Senior Director , Global Regulatory Leader, CAR-T...strategy, regional strategies, CMC-RA strategy, and commercial strategy. + Lead the Global Regulatory Team… more
- J&J Family of Companies (Trenton, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , ... more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead...exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- 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 agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or... Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy… more
- Bristol Myers Squibb (Princeton, NJ)
- …to:** + New Product Portfolio working closely with their TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and ... and maintenance of global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities include, but are not… more
- J&J Family of Companies (Horsham, PA)
- Global Medical Affairs Leader, Director , Dermatology - 2406179906W **Description** Johnson & Johnson Innovative Medicine, Immunology Global Medical Affairs, ... for a Global Medical Affairs Leader (GMAL), Director , Dermatology, located in Horsham, Pennsylvania or Spring House,...clinical development within the Immunology TA. The GMAL will lead the Global Medical Affairs Team and… more
- Amicus Therapeutics (Princeton, NJ)
- …Associate Director , External Quality Lead (Small Molecule) Amicus Therapeutics is a ... Associate Director , External Quality Lead (Small Molecule)...Regulatory and other internal partners, the EQL Associate Director is actively engaged in ensuring outsourced manufacturing is… more
- CBRE (Philadelphia, PA)
- HSE Senior Director - Retail & Enterprise Global Services/Infrastructure, Defense and Public Enterprise Sectors Job ID 151325 Posted 15-Feb-2024 Service line GWS ... America, Toronto - Ontario - Canada POSITION SUMMARY The Director of Health, Safety and Environment (HSE) has the...common cross functional HSE platform. + Collaborate with the Global Transition Platform Lead regarding HSE aspects… more
- J&J Family of Companies (Spring House, PA)
- …Clinical Development and Clinical Pharmacology experience is preferred. + Knowledge of global regulatory requirements, ICH, GCP and clinical trial terminology is ... Associate Director , Translational Clinical Medical Lead Translational...relevant stakeholders at the CDT. The TCML collaborates with Global Development Operations (GDO) and the entire Trial Team… more
- J&J Family of Companies (Titusville, NJ)
- …**Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Global Labeling Product Leader in Raritan, NJ; Titusville, NJ; ... Associate Director , Global Labeling Product Leader -...a positive impact on their communities. **Key Responsibilities:** + Lead the development, revision, review, agreement, and maintenance of… more
- J&J Family of Companies (Horsham, PA)
- Senior Director , Strategic Lead US Medical Affairs Gastroenterology - 2406177429W **Description** Johnson and Johnson is recruiting for a Senior Director , ... new technologies, and treatment modalities to restore immune homeostasis. The Senior Director , Strategic Lead US Medical Affairs Gastroenterology is responsible… more
- Wolters Kluwer (Trenton, NJ)
- …Responsibilities: + Lead the in developing audit/assessment plan for different regulatory or standard's needs. + Help mentor team members to build the technical ... have a need for a **Senior IT Technical Compliance Lead ** on the team, as this is a current...control owners and business partners on requirements from several regulatory frameworks such as GDPR, HIPAA, PCI-DSS, etc. +… more
- Bristol Myers Squibb (Trenton, NJ)
- …Responsibilities** + This role will have accountability to act as the WW Medical Lead for Eliquis reporting to the Executive Director , WW Eliquis and Established ... Read more: careers.bms.com/working-with-us . **Position Summary** The WW Eliquis Medical Lead is accountable for medical leadership, strategy and execution of… more
- WuXi AppTec (Plainsboro, NJ)
- …Small Molecule, Large Molecule and Central Lab functions at the WuXi NJ site, lead the team in bioanalytical sciences, GLP operations, and business aspects, and to ... Central Labs in China to promote synergy in supporting global clinical and non-clinical studies. **Responsibilities** + Serve as...GLP/GCLP regulations, bioanalytical guidelines, + Could serve as the lead at the New Jersey (NJ) site of WuXi… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …to the best of my knowledge. **Job Description** **About the role:** Join Takeda as a Director , Field Medical Excellence Lead where you will be a key member of ... environment to accomplish goals and objectives. + Demonstrated ability to manage, lead and mentor individuals and/or teams. + Excellent communication (written and… more
- Bristol Myers Squibb (Trenton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . The primary role of Medical Engagement Lead (MEL) is to engage in meaningful peer-to-peer scientific dialog with ... + Facilitates scientific partnerships and research collaborations in collaboration with Global Drug Development (GDD) + Provides recommendations and insights to the… more
- Novo Nordisk (Princeton, NJ)
- …include: + Clinical summary and overview documents in eCTD format for global regulatory submissions, including investigational medicinal product dossiers (IMPD), ... regulatory requirements of a clinical program. The Associate Director will provide high level strategic input into development...global and local cross-functional study teams. The Associate Director should be seen as a key resource for… more
- Merck (West Point, PA)
- …procedures to drive harmonization of processes and systems across the network. + Lead cross-functional global teams developing content for Change Control, and ... **Job Description** The Director , QMS Topic Owner role is critical in...effort to create and sustain a simplified, integrated, user-centric global Change Management Process for our human health products,… more
- J&J Family of Companies (Titusville, NJ)
- …**Required Technical Knowledge and Skills:** + Ability to effectively and strategically lead global cross-functional teams + Connect, collaborate and build ... Director , Medical Safety Officer, Oncology - 2406185159W **Description**...(HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the MSO will also lead … more