- Sanofi (Swiftwater, PA)
- …compliance, Functional Planner, Project Manager , CROs, etc.) Under supervision of the senior manager of the TED team or Research lead, participates in ... Job Title: Sr . Non-Clinical Biostatistician Location: Swiftwater, PA About the...lead statistician and provides support, with minimal supervision from manager or TED Global Head, to the… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Sr . Manager , GMP Quality Assurance is responsible for ensuring that all ... distribution of Formation Bio's portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role supports CMC… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The RoleThe Senior Manager , Clinical Programming is responsible for the establishment, governance, and ... and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions… more
- Big Belly Solar LLC (Lawrence, MA)
- …description, and then click on Apply. Location: In-person, Lawrence, MA The Senior Manager , Operations Engineering leads Bigbellys core engineering operations ... recycling systems are built with world-class quality, efficiency, and scalability. The Senior Manager will drive operational excellence across the US… more
- Sanofi (Cambridge, MA)
- …project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to ... Job Title: Senior Clinical Research Director Location: Cambridge, MA or...Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Senior Counsel, Privacy, is a strategic, business-minded, and hands-on attorney role whose job will ... and managing Eisai's US Privacy Program, the responsibilities of the Associate Senior Counsel, Privacy, include, but are not limited to, practical and timely… more
- Merck & Co. (Durham, NC)
- …by policies, procedures and business plan; receives guidance from manager .Provides technical guidance to employees, colleagues or contractorsAnticipates and ... (both minor and major), with responsibility to interface with Operations, Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough… more
- Merck & Co. (North Wales, PA)
- …readiness as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is ... support any Regulatory Health Authority inspection, worldwide.-In collaboration with the Global Inspection Coordinator and Head of CQO, maintain and QC the … more
- Merck & Co. (Rahway, NJ)
- …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
- 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
- Grifols (Brookings, SD)
- …Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being ... more than 110 countries and regions. Job Title: CENTER MANAGER Summary: Acts as the general manager ...all financial records are accurate and in order. Identifies regulatory deficiencies and in collaboration with the Center Quality… more
- Repligen (Waltham, MA)
- OverviewMake a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs ... shared success-where every voice matters and every contribution drives progress. Join us!IT Manager , SOX & ITGC ComplianceWe are seeking an experienced IT Manager… more
- SharkNinja (Needham, MA)
- About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact ... in homes around the world. Powered by two trusted, global brands, Shark and Ninja , the company has...online and offline, and through distributors around the world. Senior Electrical Systems Engineer - Advanced Development At SharkNinja,… more
- Insmed Incorporated (NJ)
- …for patients with serious diseases. In this role, you'll be reporting to the Sr . Manager , Clinical Supply Chain & Logistics.The Insmed Summer Internship Program ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for… 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 ... studies or outsourced studies with elements of insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic… more
- Cipla (Hauppauge, NY)
- …posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's US Subsidiaries or Affiliates. ... - 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this role performs and… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you ... Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… 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. (Raleigh, NC)
- **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
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing ... global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes… more
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