- Novo Nordisk Inc. (Plainsboro, NJ)
- …Act), and within defined budgeting guidance). Relationships Reports to the Executive Director OED. Accountable for managing relationships with external partners ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management: Build strong internal and external … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the ... standards through extensive collaborations with Daiichi Sankyo's internal and external stakeholders. Proven experiences in Oncology Therapeutic area with Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include ... IT, etc. Other internal relationships include Public Affairs and CMR. External relationships include relations with external consultants, patient support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training and Documentation management ... leader, however is also accountable to the VP of quality . The incumbent is expected to understand and apply...array of audiences- Edits and produces advanced internal and external communications; acts on behalf of an executive for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ... labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the... of data is suitable for regulatory submission. The Associate Director will have routine interaction with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head ... RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global...One Quality voice as the best trusted quality partner with internal and external stakeholders.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder ... will partner with internal and external stakeholders as well as vendors to optimize AI/ML...and dissemination- Identify innovative ways to improve the efficiency, quality and productivity of AI/ML activities and actively contribute… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... and manage oversight. The position will partner with internal and external stakeholders to optimize Statistical methods, processes and standards. The position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... operational focus; ensuring to establish good working relationships with internal and external stakeholders, eg, Tech Unit, SMEs. Communicate closely with Sr. CMC… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... provides leadership within Data Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function of the CMR ... and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager...and master service agreements across a broad spectrum of external entities with a focus on budget, quality… more
- Merck & Co. (Rahway, NJ)
- …are seeking a highly skilled and experienced professional to join our team as an Associate Director for our Digital Forensics Lab. The Associate Director ... workload, and ensure the lab maintains a high standard of quality and accuracy.Digital Forensics Investigations:-Conduct and oversee complex digital forensic… more
- Merck & Co. (Rahway, NJ)
- …be successful in this role.Job Summary and assignments: The successful candidate for the Associate Director , Strategy & Realization will promote HH - US, Global ... and guidelines, to ensure consistency and clarity in its execution.Monitoring quality of entries & drive user accountabilityInform visualization needs to closely… more
- Merck & Co. (Rahway, NJ)
- …that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the ... infrastructure.- Responsibilities include the following:The process/facility engineer role at the Associate Director level will serve as a technical mentor… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... for technical support as Insmed's internal SME, technical review of quality documentation, management of schedule/raw material consumption/budgets, and management of… more
- Merck & Co. (Rahway, NJ)
- …overall success of the pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the successful candidate will be an ... engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the… more
- Merck & Co. (Rahway, NJ)
- …and make informed decisions to manage their parts of the Research & Development division.The Associate Director , PMO People & Process Lead, is a unique role that ... Job DescriptionAssociate Director , PMO People & Process LeadGlobal Project and...the training forum; accountable for curating and defining a quality annual calendar of topics that achieve the purpose… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical ... and reporting of clinicals.Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams.Undertake...the discretion and latitude required in the role, and external market and internal value when determining a salary… more
