- Merck & Co. (North Wales, PA)
- …V&I Outcomes Research, V&I GMSA, BARDS HEDS, and others as determined by senior leadership by providing overall operational support for research conducted in ... compliance with Good Pharmacoepidemiology Practice (GPP), Company Policies, and Standard Operating Procedures (SOPs).Primary responsibilities include:Operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cataloging, archiving, metadata tagging, content management systems, etc. in Adobe Experience Manager (AEM) DAM. The DAM Librarian plays a vital role in the ... the access and use of digital assets, ensuring brand consistency, compliance , and copyrights Maintain DAM taxonomy, process and governance-related documents,… more
- Lundbeck (Chicago, IL)
- …journey of growth!Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager Sales Training and Development is primarily responsible for ... sales management training needs by observing individual Biopharmaceutical Account Manager performance/behaviors and collaborating with the appropriate functional areas… more
- Novo Nordisk Inc. (Durham, NC)
- …established and capable to meet quality specifications & requirements, to include GMP Compliance of the team Ensure appropriate support is on site as needed during ... production activities Coordinate all validation/transfer activities involving MDev support Lead team in successful execution of support to the productions Coordinate with Director, Bulk, Pack, QC & EM & other teams on workload issues & priorities Coordinate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to realize your potential? The Position The Senior Application Architect leads the team of skilled technical experts to design, ... develop and implement Adobe Experience Manager (AEM) solutions that support digital transformation efforts and meet the organization's business goals in a changing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryThis position will be part of the Compliance organization and will report directly to the Director, Compliance ... be responsible for creating and assisting in the development of compliance program trainings and communications, including developing eLearning modules. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure requirements and participates in the strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... Management, as necessary.Participates in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.Remain informed… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …supplier to ensure business objectives are met Monitors organizational compliance with all established supplier agreements Provides strategic procurement ... and tools: Follows up on system usage and proactively ensures compliance to system Physical Requirements 10-20% overnight travel required. Qualifications Bachelor's… more
- Merck & Co. (Lenexa, KS)
- Job Description Job Description: The Senior Specialist, US Channel Business Capabilities is a key role within our US Strategy and Business Channels organization. The ... responsibilities may include, but are not limited to:- Assist Channel Operations Manager with the development and execution of the following:Partnering with US Legal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to realize your potential? The Position The Senior Analyst will be the Master Data Management (MDM) primary Subject Matter Expert ... (PCOR) Account Management, the SME for Medical Review Committee, Compliance , Legal, Personal Promotion, and other HCP related policies....The role will also serve as backup to the Manager for Data Stewards of Patient, Customer and Product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy ... CMR organization. This position will work cross-functionally with stakeholders, including senior leadership, across all organizations within CMR as well as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …delivery of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). ... to agreed strategy and plan, optimizing speed, quality and budget in compliance with standard processes, policies and procedures Collaborates with Clinical Finance &… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA… more
- Aequor (Newbury Park, CA)
- …also useful. Coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements. Management and ... Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of regulatory documents. Technical:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and others as needed to communicate with field sales.Identify and action any policy or compliance risks and escalate to manager as neededPartner with Legal and ... sessions - both live and virtualTrack speaker utilization and work with manager to escalate as needed.Coordinates Speaker Training and working closely with the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and leadership for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Catalent (St. Petersburg, FL)
- …environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures ... of process controls in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing the activities and… more
