- Merck (Upper Gwynedd, PA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... drive our strategic priorities. The Director, Principal Scientist | Regulatory Affairs Liaison is responsible for development...by regulatory agencies. + Functions as global regulatory lead assigned to programs where the… more
- Novo Nordisk (Plainsboro, NJ)
- …difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to ... The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global...Registrations Labeling Tools: + Serve as a subject matter expert in all labeling tools (SPL, TVT, Veeva Vault,… more
- Bausch + Lomb (Trenton, NJ)
- …degree preferred (or equivalent education and experience). Minimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment. Excellent ... promote a successful product regulatory strategy and increase probability of regulatory approval + Actively lead and/or participate in project team… more
- Merck (Upper Gwynedd, PA)
- …Development Execution, The primary function includes coordinating various GRACS (Global Regulatory Affairs and Clinical Safety) functional areas, to ensure ... implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements. These agreements include but are not… more
- Taiho Oncology (Princeton, NJ)
- …such as: Clinical Development, Commercial, Evidence and Value Development, Market Access and Regulatory Affairs to ensure, as needed, alignment and inputs + ... indications. Position Summary: + The Sr. Medical Director, Medical Affairs (SMD, MA) needs to be an expert...clear understanding of all areas and functions within medical affairs and able to lead strategic development… more
- Sumitomo Pharma (Trenton, NJ)
- …and responses to unsolicited requests for medical/scientific information. + Serves as Medical Affairs Lead on select therapeutics topics, and provides input into ... Products, pre-, and post launch activities related to Medical Affairs function. This individual will lead program...Product Development Monthly Meetings. + Serve as Subject Matter Expert within Medical Affairs Team provide medical… more
- Veterans Affairs, Veterans Health Administration (Lyons, NJ)
- …and determines changes, delays or other unanticipated issues; Subject matter expert on relevant regulatory requirements; Provides technical direction to ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus Disease 2019… more
- J&J Family of Companies (Titusville, NJ)
- …+ Write or provide guidance to other writers on all types of clinical, regulatory , and safety documents, taking a proactive lead in content and scientific ... applicable), and teams. + Ability to delegate responsibility to other medical writers. + Expert ability to lead and influence by example and stay focused… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... in the US** The Director, Translational Medicine and Early Development (TMED) Lead will be responsible for contributing and/or devising the early clinical… more
- Novo Nordisk (Plainsboro, NJ)
- …Affairs (MAPA), Portfolio Strategy, Insights and Analytics, Commercial Excellence, Legal, Regulatory Affairs , and other relevant NNI departments to ensure ... on shaping our future. The Position The Hemophilia TA Lead is instrumental in shaping and executing NNI's strategic...teams + Product Evolution + Oversee product strategy and regulatory activities related to life cycle management efforts +… more
- CSL Behring (King Of Prussia, PA)
- …MA team. + Partner with and share expertise with the _global_ functions of Medical Affairs , ABC, CRD, R&D, Regulatory affairs , Global Clinical Safety & ... in the responsible TA, the Executive Director, will lead the development and execution of Medical Affairs...and compliant execution of plans. + Serve as the lead scientific and clinical expert in the… more
- Ascendis Pharma (Princeton, NJ)
- …medical information system development. + Serve as a clinical and scientific expert for Medical Affairs projects within the designated TransCon Program(s). ... is a major advantage. The candidate is expected to lead key strategic, cross-as well functional projects as part...both internal and external audiences within legal, compliance and regulatory guidelines. + Represent Ascendis Medical Affairs … more
- Novo Nordisk (Plainsboro, NJ)
- …stakeholders, especially with Medical Directors, Marketing, Marketing Operations, Legal, Regulatory Affairs and externally with agencies. Represent Medical ... external agencies. Key internal relationships include Marketing Operations, Marketing, Legal, Regulatory Affairs , Medical Affairs , Convention Marketing and… more
- Bristol Myers Squibb (Princeton, NJ)
- …the PC space + Manages relationships with key internal stakeholders including Regulatory , Clinical, Commercial, Medical Affairs & Communications and external ... after clinical proof-of-concept studies, including but not limited to regulatory submissions and life-cycle management. Translational disease strategies in… more
- J&J Family of Companies (Horsham, PA)
- …by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to ... implementation activities and team leadership for the US Solid Tumor Medical Affairs organization. The current and near-term portfolio of medicines treat Bladder,… more
- Bristol Myers Squibb (Princeton, NJ)
- …all major functions (eg, Development, R&D, HEOR, Value Access & Pricing, Regulatory , Commercial, Corporate Affairs , etc.) and building alignment with ... candidate will have an outstanding level of desire to lead people with a strong leadership track record of...support to the Cardiovascular Mavacamten program, represent global medical affairs in cross functional leadership forums. + Develop and… more
- Bristol Myers Squibb (Princeton, NJ)
- …are completed + Oversee study centers, countries, investigators and connect with PV, Medical Affairs and Regulatory Affairs + Contribute to develop Quality ... . **Position Summary** The Associate Director, Therapeutic Area Audit Strategy Lead will be mainly responsible for developing the TA audit strategy… more
- Novo Nordisk (Plainsboro, NJ)
- …the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... + Support the ALD clinical development program as medical lead and expert drug developer, providing input...Non-Clinical Research, Medical Writing, Program Management, Product Supply and Regulatory Affairs teams to deliver and drive… more
- Novo Nordisk (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Managers, and Market Access), Brand Marketing, Training, Market Access & Public Affairs , Trade, Legal, Compliance, Finance, HEOR, and Market Research. The position… more
- TD Bank (Mount Laurel, NJ)
- …as a liaison for relationships with the 1st line Exam Management teams, the Regulatory Relations and Government Affairs team, and regulatory agencies. ... to improve products, processes or services + Acts as a technical expert / lead integrating cross-function understanding within their own field of specialty;… more