- Merck & Co. (Rahway, NJ)
- …archive function in strategic planning meetings, system integration workshops, and change management initiatives. Advocate for continuous improvement in archival ... Job Description Associate Director , Regulatory Submissions Archive Operations -... management and related activities.- Proven leadership in Change Management with an ability to lead… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post ... by Technical Operations or from CMOs to support development program and life cycle management , and ensure they meet current regulatory standards, are of high… more
- SMBC (Jersey City, NJ)
- …of new products and complex transactions under US Basel and BCBS frameworks. ** Change Management & Implementation** + Advocate for and support the implementation ... portfolio of benefits to its employees. **Overview** As a Regulatory Policy Director at SMBC you will...oral, to discuss relevant and complex topics with senior management or key stakeholders. + Good understanding of US… more
- ITG Brands (Greensboro, NC)
- Director , Regulatory Science **Location** North Carolina **City** Greensboro **Role Type** Permanent **WHO WE ARE** ITG Brands is the third-largest tobacco ... the development and submission of Premarket Tobacco Product Applications (PMTAs) and other regulatory filings to the FDA Center for Tobacco Products (CTP). The ideal… more
- Merck & Co. (Rahway, NJ)
- …Skills: Adaptability, Adaptability, Business Processes, Business Process Improvements, Change Management , Clinical Research, Cross-Functional Team Leadership, ... to progress the R&D pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive… more
- Merck & Co. (Rahway, NJ)
- …RIM-based global content source management solution and function as BSOLead the Change Management and Business Process activities to drive adoption of the ... of improvement initiatives including business process design, coordination of IT activities, change management and trainingPartner with QA and Standards to… 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 ... the maintenance of signal tool and support tasks of change control, training material update, and end user support...of the material content of any documents sent to regulatory authorities. Provides compliance metrics to management ,… more
- Insmed Incorporated (NJ)
- …with regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk Management plays a critical leadership ... seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role will manage… more
- SMBC (Jersey City, NJ)
- …executive management updates and presentations. + Design and support change management programs inclusive of stakeholder assessment, impact analysis, and ... . + Ability to strategically develop and implement complex process and technology change management initiatives. + Ability to prioritize efforts across multiple… more
- Merck & Co. (Durham, NC)
- …Influence, Leadership, Networking and Partnerships, Program Management , Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance, Risk ... Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across...you'll be a core member of the Value Chain Management Team, guiding strategy, ensuring compliance, and enabling manufacturing… more
- Novo Nordisk Inc. (Seattle, WA)
- 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. (North Wales, PA)
- …been an emergence of innovative medicines and new modalities that aim to change the way we approach treatment for immune disorders. Our scientists are investigating ... Program Marketing across the Immunology portfolio.- This position will report to the Director , US Marketing Patient Support.- The Associate Director will shape… more
- Merck & Co. (Rahway, NJ)
- …with internal and external stakeholders.Required Skills: Applied Engineering, Change Management , Combination Products, Compliance Packaging, Cross-Functional ... Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate ...party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate… more
- Merck & Co. (Rahway, NJ)
- …and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, ... Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director… more
- Genmab (NJ)
- …The Director , HEOL Team Lead is responsible for the management of the HEOL team including:Ensure operational excellence of the HEOL team ... developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …where your distinct perspectives and expertise are valued as we work together to change lives for the better. The Position The Associate Director , Consumer ... role translates the corporate digital vision set by the Senior Director into best-in-class digital experiences, driving audience engagement, building brand trust,… more
- Novo Nordisk Inc. (Boulder, CO)
- …all departments, such as Quality Assurance/ Control, Chemical Development, Program Management , Regulatory , Analytical Development, Materials Management , and ... both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product… more
- Merck & Co. (Rahway, NJ)
- …across multiple therapeutic areas, including multi-country/center patient trials).The Executive Director will develop/ support an empowered organization that can ... of all operational components of clinical programs using strong project management , leadership, organizational and communication skills while ensuring GCP and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational leader...is a strategic and operational leader responsible for the management , development, and performance of all engineering operations across… more
- Insmed Incorporated (NJ)
- … change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory , Clinical Operations, and Program Management to drive ... management experience.Proven expertise in root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical… more
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