- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … 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 ... ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and...This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that… 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 ... operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing, process characterization and validation, and manufacturing CMC… more
- Merck & Co. (North Wales, PA)
- …the Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the ... automation activities throughout the facility.-Primary Responsibilities:Provide process support for clinical manufacturing and R&D processes while also facilitating tech… more
- Merck & Co. (North Wales, PA)
- …and HQ-created global Promotional Materials and Scientific Content, Medical Education and Training of internal stakeholders (eg, US Call Center, Field Sales), and ... company policies, local regulations, and department SOPs.Medical Education and Training : Create and develop medical/disease education materials. Create/adapt foundational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and...data management subject matter expert and provides guidance and/or training to study teams in preparation for upcoming audits.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …training processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management. ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...consistency and harmonization of the implementation of the CMR training strategy. Serve as the CMR Training … more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies. This translational role resides within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, development ... of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting- ... programs to generate and validate SDTM, ADaM dataset and TLFs, support technical training and ensure effective implementation of SDTM, ADaM and TLFs standard in … 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 ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Merck & Co. (Rahway, NJ)
- …and procedures and-with quality standards internally and externally.Under the oversight of the CRD( Clinical Research Director ) / Director , Clinical ... role will work across the different country operations roles (eg CRM( Clinical Research Manager), CRA( Clinical Research Associate )-Manager,-Partners, TA-Head,… more
- Merck & Co. (Rahway, NJ)
- …of engineering fundamentals. The MACS Operations Specialist position will report to the Director , Engineering and will be a member of the EF Team at the ... the Operations Specialist include the following:The Operations Specialist role at the Associate Specialist level will serve as a process team member supporting the… 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 ... and communication of HEOR evidence to demonstrate the value of Insmed's product(s). The Associate Director will work closely with HEOR team members and others… 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 ... aspects for complex clinical trial(s) or indication product line. This role leads...RangeInsmed takes into consideration a combination of candidate's education, training , and experience as well as the position's scope… more
- Catalent (San Diego, CA)
- …capabilities.Perform internal and external audits.Lead or support client audits along with the Director and Associate Director of Quality AssuranceManage a ... Job Title: Quality Assurance Associate , Analytical City: San Diego State : CA...method validation reports for analytical testing.Performing internal and external audits. Training new hires on analytical review of stability data.SALARY… more
