- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... packages for FDA meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory documents translating team strategy into … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of Novo ... reports to the Director - Accelerated Efficiencies and Optimization, Strategic Operations. The Project Manager regularly works with members of CMR to develop and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for developing unique themes, imagery, etc., under the direction of Director, Compliance Policy, Training and Communications. Project manage various teams to ... financial position of the Company in order to provide meaningful support.Provide project management support for special Compliance projects which may include… more
- Eisai, Inc (Nutley, NJ)
- …security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of regulatory , ... educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new… more
- Aequor (Thousand Oaks, CA)
- …and procedures, providing support and corrective actions where required Assists overall Project Manager with all matters related to strategic sourcing and ... to develop contracts, execute for signature, and store for compliance . Ideal Capital Projects Sourcing Manager candidate:...Project Delivery teams and suppliers Develop and maintain Project Sourcing Plan with Project Manager… more
- Merck & Co. (Durham, NC)
- …shop floor leadership.-Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line operations supervisor with ... Job DescriptionThis role is within a capital project start-up in Durham, North Carolina. The new...the design and construction of the facility, the Operations Manager will play a critical role in supporting the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups which are established to ensure continued inspection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies ... Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management. Responsibilities Leadership,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject ... and ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support secondary customer… more
- Merck & Co. (North Wales, PA)
- …coordinate, and document adherence to internal, external, and regulatory compliance requirementsCollaborate extensively and troubleshoot issues ... Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… 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
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …the Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance , will oversee end-to-end contract ... of the Office of Research Contracts (ORC).The Contracts Manager - Federal Contracts and Compliance will...DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of new reporting systems.Establish and implement programming standards and comply with regulatory requirements among project team members and across all ... well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the… more
- Lundbeck (Chicago, IL)
- …of growth!Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager Sales Training and Development is primarily responsible for managing the ... sales management training needs by observing individual Biopharmaceutical Account Manager performance/behaviors and collaborating with the appropriate functional areas… more
- Aequor (Thousand Oaks, CA)
- …support of product development? Knowledge of protein and small molecule quality, compliance and regulatory requirements? Knowledge of analytical techniques used ... Manager is requesting candidates college GPA in the...(referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The… more
- Merck & Co. (Durham, NC)
- …for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.-Responsible ... approve Operations, Technology, or Automation protocols.Leads or actively participates in project suite teams, as required.Direct support of regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to existing GCO procedural document packages.As needed, monitor 1) procedural compliance metrics to support inspection readiness activities, and 2) procedural ... as appropriate.Work with the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and maintain the curriculum… more
