- Novo Nordisk Inc. (Plainsboro, NJ)
- …To ensure compliance with all Federal regulations and company SOPs regarding safety reporting from both post-marketing and clinical trial sources for all Novo ... management and coordination of all daily operations of Product patient Safety 's case processing activities, which include the receipt, documentation, triage, case… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... with a team of individual contributor production direct reports including safety , quality, and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and ... within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to global Development governance. In this key role, the candidate will have to lead a complex, global team in charge of a global clinical program designed to ... representative of asset through the lifecycle from research to post-marketing functions. Lead all GPT meetings, ensure team and cross functional alignment, positive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Are you ready to maximize your potential with us? The Position The Product Manager is driven by a customer-centric mindset to meet business goals by leading the… more
- Catalent (Manassas, VA)
- …and procuring materials, services, and capital for the site. The Site Procurement Manager will lead site procurement team and initiate and foster relationships ... through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Catalent (Harman, WV)
- …to make a significant impact on the way that the Harman's site operates. The Manager , Supply Chain - Warehouse will lead a shift consisting of Warehouse ... The Manager , Supply Chain - Warehouse , reporting to...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Novo Nordisk Inc. (Durham, NC)
- …Management (Mdev LCM) in Emerging Technologies (ET) for the production site. Lead strategic activities ensuring new products can thrive without disrupting the ... and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead , drive & coach teams to ensure a high performing collaborative… 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 ... Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety , CROs and External Vendors for the data services they provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... outcomes. This role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG) across functional areas. This includes:… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, New ... Jersey. Role Overview The Quality Systems Lead role is an exempt level position with responsibilities...issues. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Require minimal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... of skilled technical experts to design, develop and implement Adobe Experience Manager (AEM) solutions that support digital transformation efforts and meet the… more
- Eisai, Inc (Nutley, NJ)
- …2 years of work experience in Pharma in job offered or as Product Manager /Global Delivery Lead . Also requires 2 years of leadership experience with/using the ... the functions operate today and what challenges are faced. Lead the analysis of the current state of business...Steering Committees in collaboration with Business Owner and Project Manager . Represent business needs to the broader EIT organization… more
- Novo Nordisk Inc. (Durham, NC)
- …of vendor & service contracts. Relationships Manager or Senior Manager . Essential Functions Lead reliability program with implementation of projects ... plans & spare parts stocking strategies to support operations Lead ISO 55001 Standards and Asset Management process Create...improvements using cLEAN® or Six Sigma tools Follow all safety and environmental requirements in the performance of duties… more
- Merck & Co. (Durham, NC)
- …performance objectives and departmental metricsConsults on an as-needed basis with team lead (04)/next-level manager on more complex decisions and/or issues that ... guided by policies, procedures and business plan; receives guidance from manager .Contributes to the performance and results of the department.Identifies and resolves… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality… more
- Merck & Co. (Millsboro, DE)
- …the Senior Leadership Team for the Millsboro, DE biologics manufacturing site. Lead numerous projects including process improvement and safety ... leadership of the Animal Services Department.Essential Duties / ResponsibilitiesAssociate Director: Lead and develop a team of animal care and testing… more
- Merck & Co. (Durham, NC)
- …Operations organization is seeking to hire an experienced and technically proficient people manager to lead a team of coaches, production specialists, and ... vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team and be accountable for all human resource… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable regulations and ... initiatives to enhance investigation quality, timeliness, and productivity.Key Responsibilities Co- Lead Deviation Investigations: Collaborate closely with the Quality Associate… more
