- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for ... Acts as a point of contact for escalations related to external data delivery quality . Ensures consistency in understanding and implementation of external … 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
- 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)
- …(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)
- …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)
- …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
- 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affiliate, and/or in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality . Regularly interfaces with ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… 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 ... Study Manager will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other… 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
- Insmed Incorporated (Bridgewater, NJ)
- …modalities.Assure bioanalytical tasks are executed to high scientific standards, with quality , and within agreed timelines. This entails overseeing work by internal ... facilities or external vendors, within a matrix-structured environment. No bench activities are expected from this role.Provide technical expertise on sample… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part ... and implements changes/ improvements and ensures continuity amongst sites and external CMO partners Drives plans and technology integration for facility… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HEOR is a significant contributor to the development ... evidence to demonstrate the value of Insmed's product(s). The Associate Director will work closely with HEOR...reports, value dossiers, and publications building on the high quality and scientific rigor of these deliverables. Represents HEOR… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Omnichannel Customer Engagement Strategy Associate Director will be responsible for partnering with key areas within our Company to help shape ... to healthcare professionals and consumers. The Omnichannel Customer Engagement Strategy Associate Director reports into the US Oncology Omnichannel Strategy… more
