- Cardinal Health (Trenton, NJ)
- **_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_** The _Manager, Regulatory Affairs ( Clinical Submissions)_ is ... or timelines. + **Leadership & Team Development** + Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory … more
- Merck (North Wales, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... drug development or clinical experience, preference if this experience is in regulatory affairs . + Excellent communication skills (both oral and written). +… more
- Taiho Oncology (Princeton, NJ)
- …regulatory activities for Taiho Oncology, Inc., (TOI), with general guidance from manager and regulatory affairs leadership. + Fosters collaborative, ... Associate Director, Regulatory Affairs Strategy Princeton, NJ, USA...incumbent will be assigned to lead/support one or two clinical development programs as Regulatory Lead (RL),… more
- Novo Nordisk (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... About the Department The Clinical , Medical and Regulatory (CMR) department...and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ… more
- RWJBarnabas Health (Somerset, NJ)
- Regulatory Planning Manager (Hybrid) - Somerset, NJReq #:0000170498 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas Health ... the Department through establishing, tracking project milestones and coordinating submissions. Manager assists in obtaining regulatory approval for enterprise… more
- University of Pennsylvania (Philadelphia, PA)
- …operations of clinical research proposals for their team. The Program Manager will work with Investigators and data informatics teams/programs to ensure the ... of the team's work, working closely with the CRU Regulatory coordinators to manage, review and initiate trials to...Manager for the CRU will oversee Phase I-IV clinical trials. Additional activities may include recruitment, and enrollment… more
- Sumitomo Pharma (Trenton, NJ)
- …of expiry dates and communicates changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + ... and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance… more
- Bristol Myers Squibb (Princeton, NJ)
- …US and WW Commercial, Research and Development, Global Drug Development, HEOR, Regulatory Affairs , and other global medical stakeholders. This position reports ... of the biopharma drug development and commercialization process. + Experience in clinical research and development, or medical affairs in Psychiatry/Neurology is… more
- Edwards Lifesciences (Trenton, NJ)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... clinical trials with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead +… more
- Fujifilm (Trenton, NJ)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all...at least 1-2 years direct experience as a Product Manager within HCUS/MIPD + Strong understanding of clinical… more
- Terumo Medical Corporation (Somerset, NJ)
- …(DSS) Program Manager will work closely with NA Marketing, Sales, Field Clinical , Medical Affairs , Supply Chain and TC teams to understand the established ... Dual Sensor Program Manager Date: Nov 28, 2024 Req ID: 3487...and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients.… more
- Integra LifeSciences (Princeton, NJ)
- …brochures and seminars + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line ... patient outcomes and set new standards of care. **Global Senior Product Manager ** Reporting to a Senior Director, Global Marketing - Codman Specialty Surgical,… more
- Integra LifeSciences (Princeton, NJ)
- …brochures and seminars + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line ... trimming, forecasting, pricing strategies, literature/video/sales support materials, labeling revisions, clinical studies, manufacturing and customer service/operations support for existing… more
- J&J Family of Companies (Titusville, NJ)
- …a Director, Strategic Communications & Learning (SC&L), part of the Scientific Affairs Value & Evidence Scientific Engagement (V&ESE) team, supporting Oncology or ... The Value & Evidence Scientific Engagement (V&ESE) organization, within Scientific Affairs , engages with Population Health Decision Makers (PHDM) across the product… more
- Terumo Medical Corporation (Somerset, NJ)
- …work with stakeholder departments such as Engineering, Operations, Clinical , Medical Affairs and Regulatory Affairs on Post Market Surveillance strategy ... products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part… more
- J&J Family of Companies (Trenton, NJ)
- …not limited to MSL field partners, R&D, US as well as Global Medical Affairs teams, clinical operations, sales, and marketing teams + Demonstrate strong ... by scientific and business needs. The MSL is considered a scientific and clinical knowledge lead on current and future J&J Innovative Medicine products per… more