- 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
- 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
- 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
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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
- 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
- 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
- Envista Holdings Corporation (Quakertown, PA)
- …+ Collaborate with Tech Support, Customer Service, Engineering, Quality Assurance, and Regulatory Affairs teams to assess trends, identify areas for improvement, ... growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced… 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: Dec 27, 2024 Req ID: 3487...and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients.… more
- AbbVie (Florham Park, NJ)
- …(eg, product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs , and Medical ... is seeking an experienced statistician to join our growing Safety Statistics team. The Senior Manager in the Safety Statistics Group will be a member of one or more… more
- AbbVie (Florham Park, NJ)
- …of work may include clinical trials, patient safety, and global medical affairs . The Senior Manager works independently in partnership with experts in ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Statistics provides statistical leadership to support the research and… 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)
- …presentation and communication of product information. Reviews all materials with Marketing, Regulatory , Medical Affairs , and legal team to confirm the standards ... for product line extensions, literature/video/sales support materials, labeling revisions, clinical studies, and commercial operations processes and tools supporting… 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
- 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