- Ascendis Pharma (Princeton, NJ)
- … Safety Databases (Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA safety ... for employees to grow and develop their skills. The Director , Head, ICSR Management Team reports to the Head,... regulatory guidance documents; working knowledge of global safety regulations. + Ability to travel up to 20%… more
- Bristol Myers Squibb (Madison, NJ)
- …Science and Technology, Business Process Management, Internal and External Manufacturing, Regulatory Affairs, Brand Teams, Legal, Patient Safety , Medical ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Cell Therapy Quality Compliance, is responsible for ensuring robust… more
- J&J Family of Companies (Raritan, NJ)
- …profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Labeling Product Leader. This position is a...+ Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners (clinical,… more
- RWJBarnabas Health (New Brunswick, NJ)
- …initiatives at RWJUH, including but not limited to: The current National Patient Safety Goals Federal, state and voluntary regulatory standards JCAHO, CMS, ... Asst Director Patient CareReq #:0000204729 Category:Nursing Manager Status:Full-Time Shift:Night Facility:RWJ New Brunswick Department:Post Intensive Care Unit-I Pay… more
- Regeneron Pharmaceuticals (Warren, NJ)
- The Director Clinical Sciences, Hematology, leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and ... of study data of a clinical development program. The Director leads in a matrix environment as part of...as key functional advisor or representative for the CS group ; ensures alignment of process and procedures for CS… more
- J&J Family of Companies (Titusville, NJ)
- …numbers, your applications will be considered as a single submission. **Purpose:** The Director of Regulatory Medical Writing (RegMW) is recognized as a leader ... medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director , RegMW has the...guidance to other writers on all types of clinical, regulatory , and safety documents, taking a proactive… more
- Merck (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director ... **Job Description** The Senior Director (Sr. Principal Scientist) has primary responsibility for...execution of clinical studies. Work closely with a cross-functional group of experts in commercialization, regulatory affairs,… more
- J&J Family of Companies (Titusville, NJ)
- …the broader R&D data ecosystem. + Engage with Clinical Development, Clinical Operations, Safety , Regulatory , Medical Writing, and external partners to align on ... a pharmaceutical company of Johnson & Johnson is recruiting for a ** Director ,** **R&D Data Science** **-** **P** **atient** **Mastering** **,** **Consent &… more
- J&J Family of Companies (Raritan, NJ)
- …study reports and for the preparation and approval of essential documents for regulatory filings. Performs medical safety data review, including evaluation of ... regulatory affairs, data management, medical writing, biostatistics, drug safety and benefit-risk management, pharmacogenomics, drug discovery, early clinical… more
- Merck (Rahway, NJ)
- …+ Ensure that all activities are conducted with the highest regard for safety , quality, and regulatory compliance, aligning with the company's divisional and ... **Job Description** **Job Summary:** The Director , Combination Product Commercialization is a key leadership role within the Device Development and Technology… more