- Bausch Health (Bridgewater, NJ)
- …drive our collective progress and impact. Responsibilities: + Manages or represents Regulatory Affairs on the US promotional review committees for prescription ... of market promotional and advertising strategies. + Updates the Regulatory Affairs advertising and promotion staff, review... advice, response to FDA action letters, and helps lead the company in discussions with OPDP. + Implements… 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
- 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
- Novo Nordisk (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... collaboration - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International +… 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
- Sanofi Group (Bridgewater, NJ)
- …what you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully accountable ... **Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ...in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global), in… 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
- J&J Family of Companies (Raritan, NJ)
- …for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Writing **Job Category:** Professional ... - 920 US Hwy 202 **Job Description:** **Manager, Oncology Regulatory Medical Writing** At Johnson & Johnson Innovative Medicine,...Prepare and finalize all types of clinical documents. + Lead in a team environment. Work with a high… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Global Medical Expert , nirsevimab **Location** : Bridgewater, NJ / Morristown, NJ **About the Job** Under the supervision of the Global Medical Brand ... Lead , nirsevimab, provide medical strategic advice/expertise for the Sanofi...the medical insights + Provide medical input to all regulatory and pharmacovigilance activities related to lifecycle management of… more
- Sanofi Group (Bridgewater, NJ)
- …Provide medical input for the definition of and alignment with the Franchises & Regulatory Affairs strategies for Marketed products + Support priority markets in ... **Job title** : Global Medical Product Lead (Recombinant Influenza Vaccine) **Location:** Bridgewater, NJ **About the Job** Sanofi Vaccines is the Global Business… 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
- 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
- SHI (Trenton, NJ)
- …will work at the direction of the Director of Government and Education Affairs and with Account Executives and SHI's government consultants to help position SHI ... revenue. The GEA Strategist will report to the Sr. Director of Government & Education Affairs and is a remote position with Home Office setup as determined by SHI… 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
- J&J Family of Companies (Raritan, NJ)
- …advocacy + Apply understanding of the external environment to support Global Regulatory Affairs and promote novel product development approaches + Provide ... in Trade Association initiatives, as well as commenting on guidance documents and regulatory programs. + Provide expert help and interpretation of meaningful … 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