- 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
- Hackensack Meridian Health (Hackensack, NJ)
- …to transform healthcare and serve as a leader of positive change. The ** Manager , Regulatory Affairs ** is assigned the responsibility/accountability for ... liaison with Joint Commission. **Responsibilities** A day in the life of a ** Manager , Regulatory Affairs ** at Hackensack Meridian _Health_ includes: +… more
- Merck (Rahway, NJ)
- …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
- ConvaTec (NJ)
- …this job description. **Principal Contacts** Internal - Marketing, Operations, Regional Regulatory Affairs , R&D, Quality, Clinical , Business-2-Business team ... us on our journey to #ForeverCaring as a Senior Regulatory Affairs Specialist, and you'll drive progress...members are home based and face-to-face contact with line manager and peers may be required. Attendance of relevant… more
- Stryker (Mahwah, NJ)
- …sources and partners with other functions such as Clinical Operations, Medical Affairs , Regulatory Affairs and Marketing to obtain regulatory ... and support from division Global Customer Excellence, Global Commercial Excellence and Clinical Affairs senior leadership. + Ensures strategic alliances with… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** The Product Manager , Analytics for Medical Affairs will lead the development, and ... the medical affairs function. + Ensure analytics solutions adhere to regulatory standards, such as HIPAA, GDPR, and other healthcare data privacy regulations. +… more
- J&J Family of Companies (Raritan, NJ)
- …closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, Medical Writing, Clinical ... Johnson and Johnson is recruiting for a Regulatory Program Manager , Oncology. This position...degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related discipline. Advanced… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Operations, Chemistry, Manufacturing and Controls (CMC), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing departments. + Identifies suitable ... and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required… more
- Hackensack Meridian Health (Neptune, NJ)
- …executed. + Works on special projects for Research department quality assurance, regulatory affairs and education sections, including review and submission of ... mission to transform healthcare and serve as a leader of positive change. The ** Manager , Clinical Research Center Operations** is responsible for Clinical … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all ... in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality...to deliver live changing therapeutics to those in need._ ** Clinical Trials Manager , Clinical Operations… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …decisions and guide product strategy -- Including cross-functional collaboration with R&D, Medical Affairs , Market Access, Regulatory Affairs and Marketing + ... Reimbursement: submissions, payment issues, policy statements, HTA submissions + Medical/Scientific Affairs : clinical study development support and execution +… 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 (Madison, 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …through collaborative efforts with all levels of other functional areas (eg, R&D, Regulatory Affairs , Medical Affairs , HEOR etc.). Uses fact-based data ... best self. Become a **maker of possible** with us. **Senior Global Marketing Manager - Strategic Marketing & Innovation** **Job Summary** The Senior Global Marketing… 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
- ConvaTec (NJ)
- …Management, and Executive Management, Global quality management, Site Quality Leads, R&D, Regulatory Affairs , Clinical Affairs , Quality Engineering, ... more. Join us on our journey to #ForeverCaring as a Corporate Complaint Manager , and you'll drive progress that really means something. **Position Overview:** This… more