- Merck & Co. (Millsboro, DE)
- …operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits, ... Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs, EHS, Engineering, BTS, ATS and HR.Direct technical… 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. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure… more
- Genmab (NJ)
- …you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and ... policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report... Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This ... with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject matter expert on the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Associate Director , Compliance Operations will be a key member of Eisai's US Ethics & ... US monitoring activities, managing in-house efforts and third-party vendor engagements. The Associate Director will also play a critical role in advancing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- Genmab (NJ)
- …and feel like a fit? Then we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of ... as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Merck & Co. (Rahway, NJ)
- …execution, along with leadership skills to shape the technical capabilities lead a global , cross-modality technical team.The Associate Director will lead a ... into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be responsible… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , EDC Programming will lead and oversee EDC ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning ... focus of these plans and activities will be either global , US-focused with intended use and adaptation by other...ManagementEisai Salary Transparency Language:The base salary range for the Associate Director , Medical Education - Oncology is… more
- Merck & Co. (North Wales, PA)
- …compliant supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. ... device component source changes.The incumbent will lead or support complex global and site-centric capital and equipment projects.- These projects would include… more
- Merck & Co. (Rahway, NJ)
- …real estate solutions to meet the needs of our Company's global businesses units, including those in Manufacturing, Commercial, Technical Operations, Research ... Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison...external consultants to gather input and facilitate planning initiatives?Our Global Real Estate Workplace Strategy team is seeking an… more
- Merck & Co. (North Wales, PA)
- …recommendations.Role in medical/legal/ compliance (CRT) reviews-Understanding of the US and Global regulatory stages and requirements-Job Owner - Fully ... Job DescriptionOur Company's Global Human Health Division abides by a "patient...& Disease learning resources for both the US and Global markets to ensure the knowledge, readiness and confidence… more
- Monster (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 ... areas centered around rare diseases and immune disorders. Summary The Senior Director of Clinical Operations will manage clinical operations staff to ensure the… more
- Monster (Bernards, NJ)
- …a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines. Develop quality systems and… more
- Monster (Bernards, NJ)
- …including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...drug trials or for approval of CDx.Keeps abreast of regulatory and policy updates in the external environment and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, ... Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting into the Director Packaging Platform Technical Leadership the Associate Director Medical Device and Combination Product (MDCP) Platform ... of commercialized products for the benefit of patients. The Associate Director of MDCP Platform Packaging and...generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and… more
- Merck & Co. (Durham, NC)
- Job Description Position Description: The SME Associate Director , Electrical & Utilities Engineer is a member of the Plant Engineering team providing direct ... (both minor and major), with responsibility to interface with Operations, Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough… more
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