- GEE Group Inc (Columbus, OH)
- …various aspects of environmental, health, and safety programs, including waste management, regulatory reporting , safety procedures, and project management. ... and providing necessary training to relevant personnel. Manage permits and regulatory reporting , including annual permit evaluation, PTIO, EPA submissions,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … reporting systems.Establish and implement programming standards and comply with regulatory requirements among project team members and across all ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is...the Biostatistics and Data Management teams on various clinical projects and may function as the Lead Clinical Data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs teams and cross-functional project team members, to gather ... centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key...(GRA) Process Excellence function, responsible for driving data governance, reporting , and analytics for RA. This will include working… more
- Aequor (TX)
- …devise) Support the NBL Manager in Lifecycle Change Management projects . Pro-actively interacting with Site Regulatory Assessors on Change Notifications, ... tools to track NB submissions for all Notified Body projects . Support the maintenance of Product and QS EC...Notification reporting requirements Support the implementation of project related " regulatory excellence" activities as part… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …smaller number of projects /studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects /studies ... Position manages end-to-end delivery of data management services for assigned projects /studies, collaborating with CROs and other vendors to ensure high quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted ... flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics. Support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise at the Project level for at least two global development projects that have been submitted to regulatory agencies preferred Travel Ability to ... ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory and ... characterization for drug substance, drug product and reference standards. The Manager must possess a good understanding of pharmaceutical development processes from… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …As a member of the Total Rewards CoE, the Global Employee Shares Manager will be responsible for managing and administering the company's global employee share ... Americas Lead certain areas of share plan administration such as financial reporting , recharge process, and tax compliance Collaborate with Legal and Finance… more
- Eisai, Inc (Nutley, NJ)
- …and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with ... and summary reports for submission to the FDA and International Regulatory authorities.Interface with other Eisai Departments and affiliates for dissemination of… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …GSA, Federal, HHS and DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …financial position of the Company in order to provide meaningful support.Provide project management support for special Compliance projects which may include ... business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Durham, NC)
- …the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead, drive & coach teams ... in place to execute the plan Ensure tracking & reporting of KPI's Ensure knowledge transfer & alignment with...members & other teams Ability to lead task & project teams Ability to manage a changing work environment… more
- Novo Nordisk Inc. (Irvine, CA)
- 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …assigned protocols and sites in a-country.-Under the oversight of the CRA manager the person ensures compliance of study conduct with-ICH/GCP and country ... regulations, policies and procedures, quality standards and-adverse event reporting requirements internally and externally.Acts as primary site contact and site … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by Manager , Quality Assurance Review and assess Corrective and Preventive Actions Reviews and ... documentation Reviews and assesses deviations; includes tracking, follow-up and reporting /trending Reviews manufacturing and support records to certify compliance… more
- DivIHN Integration Inc (Waukegan, IL)
- …and processes used to develop and implement strategic and tactical application and infrastructure projects . The Project Manager is involved in the management ... Project Manager , is responsible for gathering and documenting all project results and then reporting or presenting them to the appropriate parties.… more
