- 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
- 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 ... business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and...team in developing and tracking its annual and periodic Compliance policy and procedure plan, including the… more
- Merck & Co. (Durham, NC)
- …will be responsible for activities that support Good Manufacturing Practice and regulatory compliance during product manufacturing within the respective VMF's to ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… 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
- Merck & Co. (Durham, NC)
- …the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team, ... shop floor leadership.-Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line operations supervisor with a team… 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)
- …with key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and company trade association group ... around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan… more
- Insmed Incorporated (San Diego, CA)
- …monitors accreditation and inspection standards, keeping the laboratory in compliance with regulatory standards.Coordinate inventory monitoring, sample, tests ... QC database. Set up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well as prioritize tasks… more
- Legend Biotech USA, Inc. (NC)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Regional Sales Manager , Southeast as part of the Commercial team based within the Territory. Role ... Overview The Regional Sales Manager (RSM) will be responsible for strategically building and...the highest ethical standards and will adhere to the regulatory requirements of the FDA and other government agency… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...and evaluates quality processes and system standards to ensure compliance with applicable Janssen standards, industry standards, and global… 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 ... actively participates in project suite teams, as required.Direct support of regulatory inspections and audits.Direct support of validation activities and all other… more
- Novo Nordisk Inc. (Irvine, CA)
- …research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Merck & Co. (Durham, NC)
- …guided by policies, procedures and business plan; receives guidance from manager .Manage multiple priorities and advance several tasks in parallel.Must be flexible ... maintenance and repair of equipment using Hazardous Energy Control Procedures. Compliance with current good manufacturing procedures(cGMP), safety and environmental… more
- Atrium Health (Charlotte, NC)
- …high quality patient outcomes. Ensures that unit operations and employees are in compliance with the Nursing Practice Act, regulatory agency standards, and ... Atrium Health is seeking a Registered Nurse (RN) Manager , Pediatrics for a nursing job in Charlotte, North Carolina.Job Description & RequirementsSpecialty:… more
- Genmab (Monmouth Junction, NJ)
- …best, and authentic is essential to fulfilling our purpose. Associate Digital Product Manager , Global Drug Safety and Pharmacovigilance This person will be based out ... at Genmab! The Role: As an Associate Digital Product Manager in IT & Digital, you will have a...as well as revalidation/ongoing deliverables needed to maintain GxP compliance beyond initial release Provide technical guidance and mentorship… more
- Genmab (Princeton, NJ)
- …as code (IaC) tools (eg, Terraform, Ansible). Solid experience with Compliance ( Regulatory and Industry) and Security frameworks Demonstrated experience ... Develop and implement automation scripts to integrate security testing and compliance checking into the development lifecycle. Collaboration and Training: Work… more
- Detroit Medical Center (Detroit, MI)
- …the appropriate level of care Compliance with state and federal regulatory requirements, TJC accreditation standards and Tenet policy Educating payors, ... related to covered services and administration of benefits and compliance The individual's responsibilities include the following activities: Securing and… more
- Genmab (Concordia, NJ)
- …coding practices, adhering to best practices for GxP, GDPR and other regulatory compliance . Monitor and analyze DevSecOps pipelines and practices, identifying ... team using the likes of GitLab, Kubernetes, AWS Cloud Formation, AWS Systems Manager , AWS Config, etc. Architect and manage infrastructure as code, utilizing tools… more
- Genmab (Whittingham, NJ)
- …working in agile and product-oriented development teams Solid experience with Compliance ( regulatory and industry-specific) and Security frameworks Demonstrated ... stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US Market and Commercial Teams (and...and Global Head of Information Security and Risk & Compliance , playing a strategic role in the Information Security… more
