- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good ... Participate in regulatory inspections and assist in preparing response documentation. **Audit Program Execution** + Contribute to the development of the annual audit… more
- Novo Nordisk (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... overall management of vendor operations and all projects related to the program . This position specializes in contact center patient support inclusive of digital,… more
- Integra LifeSciences (Princeton, NJ)
- …and impactful patient care worldwide. Integra Life Sciences is looking for a Senior Manager , Digital Process Optimization with a proven track record of ... and general surgery, and regenerative wound care, including the first FDA -approved artificial skin. By combining advanced surgical tools with biologic regenerative… more
- Ascendis Pharma (Princeton, NJ)
- …workplace for employees to grow and develop their skills. The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, providing project ... knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA , EMA, ICH, etc.) and global eCTD submission requirements (eg, US,… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …models and scientific data and draw out key messages + Understanding of FDA , ACCME, PhRMA regulations + Proficiency in Microsoft office suite with strong command ... 401(k) savings plan; flexible spending accounts; and the employee assistance program . Employees also receive various paid time off benefits, including vacation… more
- Pentax Medical (Montvale, NJ)
- …manufacture of Speech , Voice and Swallowing products. + Facilitate all FDA registration and listing related activities. + Manage interactions with US Customs and ... and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are...environment. PENTAX Medical is proud of its comprehensive benefits program and generous Paid Time Off and Holiday policy.… more
- Bayer (Newark, NJ)
- …and diverse minds to make a real difference, there's only one choice.** ** Senior Medical Science Liaison Stroke/Thrombosis New York New Jersey** Senior Medical ... **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Senior Medical Science Liaison, Stroke/Thrombosis are to: **Scientific Expertise** +… more
- Integra LifeSciences (Princeton, NJ)
- …and in compliance with industry standards. + Support the Environmental Controls Senior Manager with providing direction to the team, coordinating workflow, ... **SUMMARY** We are seeking a highly skilled and motivated Senior Process Engineer II with a focus on bacterial...ANSI/AAMI ST72, ISO 11737-3, USP <85>, USP <161>, and FDA guidelines. + Ensure proper integration of endotoxin testing… more
- BioLife Plasma Services (Trenton, NJ)
- …supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll ... employees. + **Career Advancement:** Work towards obtaining a Plasma Center Operations Manager position by completing the training program , networking, and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Senior Clinical Research Director **Location:** Cambridge, MA or Morristown, NJ **About the Job** Join the engine of Sanofi's mission - where deep ... turn the impossible into possible for millions. As the ** Senior Clinical Research Director** ( Senior CRD) within...or several indications in the Development of an R&D program ** . The role requires medical leadership, organization skills… more