- 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...following an agreed upon plan. The incumbent conducts the regulatory activities to ensure high quality , … 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....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
- Sumitomo Pharma (Trenton, NJ)
- …a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Medical Affairs Technology and Digital Innovation** . **Job Duties ... affairs content + Implements innovations with respect to quality control mechanisms, supportive systems/databases, efficient inquiry handling workstreams, and… 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
- Cardinal Health (Trenton, NJ)
- …liaison with Strategic Sourcing, Process Engineering, Design Quality , R&D, Medical Affairs , Quality Compliance and Governance, Regulatory , and other ... policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Supplier Quality is responsible for… more
- J&J Family of Companies (Raritan, NJ)
- Johnson and Johnson is currently seeking an Senior Local Trial Manager . This position can be located remotely within the United States. At Johnson & Johnson, we ... for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries....in a country or countries. The Senior Local Trial Manager is the primary point of contact at a… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …and EU standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team to ensure that ... represented at the Labeling cross functional teams including clinical, safety, medical affairs , device regulatory and commercial, to ensure highly effective… more
- Merck (Rahway, NJ)
- …processes, and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high- quality standards. Product managers ... cross-functional teams to develop and implement pharmacovigilance strategies that meet regulatory requirements and ensure patient safety, quality and compliance.… more
- Integra LifeSciences (Princeton, NJ)
- …Collaboration and Stakeholder Management** + Collaborate with key functional leaders (eg, Regulatory Affairs , Quality Assurance, Manufacturing, Legal, and ... address quality and compliance gaps across the organization. The CMP Program Manager will be working alongside the VP, Quality Compliance to provide tactical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …required + 4 or More Years Minimum of 3 years of experience in regulatory affairs required + Project Management knowledge and certification preferred + Proven ... and clear communication with stakeholders and the project team. The Project Manager identifies and mitigates risks, maintains high- quality deliverables, and… more
- Cardinal Health (Trenton, NJ)
- …Reporting technology, Controlled Substance Ordering System (CSOS) platforms support & governance + Quality & Regulatory Affairs (QRA) technology (eg, Federal ... LRCGQ IT is accountable for all technology solutions for the Legal, Regulatory Compliance, Government Relations, & Quality (LRCGQ) organization. The team… more
- Terumo Medical Corporation (Somerset, NJ)
- …relevant experience in the Catheterization Lab. Familiarity with Product Development, Quality / Regulatory Management, Commercial Operations, & Supply Chain roles ... Dual Sensor Program Manager Date: Dec 27, 2024 Req ID: 3487...develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of… more
- Edwards Lifesciences (Trenton, NJ)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- AbbVie (Florham Park, NJ)
- …areas 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 ... and set new standards of care. **Global Senior Product Manager ** Reporting to a Senior Director, Global Marketing -...competition + Collaborates with sales to ensure a high quality of sales support in terms of new product/market… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products. ... areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products. ... therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all clinical trial activities are… more
- WM (Newtown, PA)
- …the desired outcomes. This role has heavy focus on environmental compliance and regulatory affairs . **Strongly Preferred skills** : + Knowledge of environmental ... and maintenance work at assigned sites to ensure the quality and timeliness of the work. + Conducts, provides...requirements. + Acts as a liaison, where necessary, in regulatory and community relationships. + Complies with and ensures… more
- Terumo Medical Corporation (Somerset, NJ)
- …Summary** The Senior Quality Compliance Engineer will work with the Senior Manager of Quality Compliance to ensure Terumo Medical Corporation is achieving ... for all new and revised external regulations and standards. + Partner with Quality Compliance Process Manager to establish time-bound product plans to conduct… more