- Eisai, Inc (Nutley, NJ)
- …want to hear from you.JOB SUMMARY:As a member of the Data Analytics group, the Associate Director , Commercial Analytics is part of a high performing team that ... reporting and validation testing standards for the department, and monitors compliance with these standards.Oversee data quality management process for assigned… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Merck & Co. (Rahway, NJ)
- …Code of Conduct and the Ethics Ambassador Program, developing ethics and compliance training workshops and communications, and managing other key initiatives in ... candidate's ability to work effectively with colleagues within the Ethics and Compliance Office (ECO) and across divisions, functions, and regions. This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Merck & Co. (Rahway, NJ)
- …for all external POs in support of SAP Platform initiatives and operations .Managing collection and tracking process for resources (internal and external) and ... forecastStrong partnership and alignment with EIT Finance and IT PMOEnsure compliance with IT financial controls and standardsQualifications, Skills & Experience:… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the ... to onboard new technologies, facilitate tech transfer, and ensure efficient operations . Communication, organization, and solid controls experience will be critical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in… more
- Merck & Co. (Rahway, NJ)
- … experience and a strong understanding of engineering fundamentals. The MACS Operations Specialist position will report to the Director , Engineering and ... infrastructure.- Responsibilities of the Operations Specialist include the following:The Operations Specialist role at the Associate Specialist level will… more
- Merck & Co. (Rahway, NJ)
- …to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide ... the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …understanding of New Account proceduresUnderstanding of Securities Processing operations and Broker/Dealer Compliance policies and proceduresExperience ... Job Description:The RoleAs a Director in the Restricted Stock Services (RSS) team,...delivering excellent service with a keen eye towards regulatory compliance . You will provide supervision, mentorship, education to your… more
- Merck & Co. (Rahway, NJ)
- …Aquaculture organization, across the biopharma and technology portfolio.Reporting to the Associate Vice President, Livestock Business Unit Lead, the incumbent is ... Development, R&D, Finance, Learning and Development, Communications, HR, Legal, Compliance .External Key ContactsKey Customers, Industry Associations, Key Opinion Leaders,Animal… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the ... of hourly personnel who are accountable for the 24-hour operations of the site.- The Manager is the first...NJ and is a 12-hour rotating shift. Position Duties: Compliance - Accountable for creating and sustaining a culture… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate ) and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a ... phases of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA (Clinical Research Associate ) and/or CRA Manager, acts as primary site contact and site manager-throughout all phases of a ... of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP,-Sponsor SOPs, Local Laws & Regulations, Protocol, Site… more
- Merck & Co. (Rahway, NJ)
- …operations roles (eg CRM(Clinical Research Manager), CRA(Clinical Research Associate )-Manager,-Partners, TA-Head, CRD and Sr.COM) to ensure alignment and ... for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, company policies and procedures… more
