- Merck & Co. (Rahway, NJ)
- …Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research ... Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal… more
- Merck & Co. (Rahway, NJ)
- …pipeline into reality bringing lifesaving medicines to our patients worldwide. Global Impact:Collaborate with colleagues across the US and internationally to ... work will shape the future of biologics on a global scale.Key Responsibilities:Technical Strategy:-Deliver robust DS strategies for successful commercialization.… more
- Repligen (Waltham, MA)
- …will a key role in ensuring the quality, compliance, and performance of Repligen's global supplier base. This is an opportunity to contribute to meaningful work on ... highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role… more
- Merck & Co. (Rahway, NJ)
- …experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well ... manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence clinical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... research areas centered around rare diseases and immune disorders. Responsibilities- GLOBAL CHANNEL STRATEGY CREATION (LINKEDIN PRIORITY)- Lead the development and… more
- Aequor (Thousand Oaks, CA)
- …will begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do Let's do this. Let's change the ... you will report to the Planning Lead within the Global Supply Chain Organization and will be accountable to...strategies. Ensure every patient every time by driving supply risk mitigation strategies to ensure supply continuity with engagement… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... of GxP audits assigned in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned with the company's strategy and… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval ... such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... us? The Position: This highly technical position directly participates in Global Security Operations activities including prevention, detection, and response to IT… more
- Merck & Co. (Rahway, NJ)
- …make a meaningful impact and drive innovation in the healthcare industry? The Global Pharmaceutical Organization (GPO) at our company is excited to invite passionate ... individuals to join our dynamic team!GPO is a diverse global organization committed to bringing a compliant, reliable supply of life-saving and affordable medicines… more
- Merck & Co. (Rahway, NJ)
- …Enhancement and System Monitoring related initiatives.Serve as a liaison between the Global Labeling Business Users of the Systems and the associated IT Partners ... aligned with the current system version. Work collaboratively with stakeholders in Global Labeling, System Support Team, IT and Learning & Development organizations… more
- Merck & Co. (Rahway, NJ)
- …apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations for ... experienceHas broad knowledge of medical device development, design controls and risk managementLed and managed development of DHF (design history file) deliverables… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Company is a trusted global leader in human and veterinary medicine, dedicated to preserving and improving health, well-being, and performance.- ... We are a global team of Environmental Health and Safety (EHS) professionals...complying with one or more regulatory programs: RCRA and High- Risk Work (eg elevated work, confined space, hot work,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy...across different disease areas, and the ability to determine risk factors with and for other technical departments (eg,… more
- Merck & Co. (Durham, NC)
- …Company Overview Our company in the United States and Canada, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our Manufacturing Division is a team of dedicated, energetic individuals… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... regulations and guidelines.ResponsibilitiesResponsibilities (Essential Role Responsibilities):Establish and maintain a risk -based and scientific-based quality system to support GCP.Oversee regulatory… more
- Merck & Co. (Durham, NC)
- …Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, ... provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer,… more