- 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)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Medical Affairs (GMA) Oncology- Medical Content ... is responsible for execution of global scientific and training deliverables. The Associate Director develops and executes Medical Content and Training plans… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with clinical and medical teams, CROs and other vendors to ensure high quality of coding deliverables to support drug development processes and global submissions. ... provides leadership within Data Management by partnering with internal and external stakeholders to optimize medical coding processes, technology, and standards.… 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)
- …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)
- …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)
- …other research areas centered around rare diseases and immune disorders. Summary The Director of Metrics and Benchmarking is responsible for cultivating a culture of ... Define and implement a model to measure Key Performance Indicators, Key Quality Indicators, Key Risk Indicators and other targeted operational metrics across each… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory… 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)
- …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
- 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
