- Novo Nordisk Inc. (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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... (GMPs) and other applicable worldwide regulations and our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of ... and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions… more
- Genmab (NJ)
- …quality, and scientific integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our ... diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and...science through compelling clinical and regulatory documents. You'll be at the heart of a… more
- Merck & Co. (North Wales, PA)
- …leadership, technical skills, and scientific acumen as part of a global , cross functional team.Job ResponsibilitiesResponsible for leading specific aspects of ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… 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 ... centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring)...of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires… more
- Genmab (NJ)
- …industry for Programming Manager , at least 6-8 years of experience for Senior Programming ManagerHas experience working in a global contextProficient in both ... diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and...developing and writing corresponding SAS or other programs. The Senior Programming Manager may also serve as… more
- Aequor (Thousand Oaks, CA)
- …- /hour Urgent role. Shortlisting will begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do ... you will report to the Planning Lead within the Global Supply Chain Organization and will be accountable to...With the end-to-end supply chain oversight of products, the Senior Manager will be responsible for establishing… more
- Merck & Co. (North Wales, PA)
- …BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through ... teams both as a direct manager and a second line manager (ie, managers of managers)Demonstrated collaboration with senior cross-functional leadership in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and ... Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise… more
- Repligen (Waltham, MA)
- …role is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, ... 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… more
- Merck & Co. (Durham, NC)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy US and Canada is ... with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director, or Director), in the… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides… more
- Valvoline Global (Lexington, KY)
- **Why Valvoline Global Operations?** At Valvoline Global Operations, we're proud to be The Original Motor Oil, but we've never rested on being first. Founded in ... committed to creating sustainable solutions for a better future. With a global presence, we develop future-ready products and provide best-in-class services for our… more
- Global Foundries (Austin, TX)
- …that is changing the world. For more information, visit www.gf.com. Essential Responsibilities The senior manager , Global Tax Planning, will be a strategic ... leading semiconductor foundries and the only one with a truly global footprint spanning three continents. We manufacture complex, feature-rich integrated circuits… more
- J&J Family of Companies (Raritan, NJ)
- …as a single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Analyst, Regulatory Program Manager - Oncology. This position is ... Titusville, NJ; Horsham, PA; or Spring House, PA. The Senior Analyst, Regulatory Program Manager ...projects forward through the translation and distillation of overall global regulatory strategy to executable plans and… more
- Insight Global (New York, NY)
- Job Description Insight Global is looking for a Senior Regulatory Project Manager to join one of our financial clients in NYC. This individual will be ... being the principal liaison between the business, IT, and senior leaders to provide management and oversight on the...10 + years of professional experience working as a Regulatory Project Manager working within financial services.… more
