- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for ... - Leadership, Direction, and Strategy:Leads implementation of Therapeutic level clinical data collection requirements including cross-functional standards initiatives by… 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)
- …management sciences, and risk management tools and resources.- Risk Management Compliance Inspection Readiness Champion. Serve as member of Risk Management office ... to ensure risk management activities allow for effective preparation for inspections/audits. Serve a key support during Risk Management Inspections.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- 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 (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you.The Associate Director , Strategic Content Development, Global Medical Affairs - Alzheimer's ... of symposia at major AD congresses and medical advisory boards, and scientific communication.The Associate Director is a key member of the NBG group responsible… 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
- Merck & Co. (North Wales, PA)
- Job Description Position Description: Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease The Regulatory Affairs Headquarters ... Associate Principal Scientist supports products in the Vaccine and...Control (CMC) as well as other functional areas (eg, Clinical Research, Safety Assessment).Supports maintenance (eg, quality compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the coded data, and adherence to regulatory authorities' requirements.Ensure compliance with the protocol, external/internal standards, Good Clinical ... end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs and other vendors to ensure high quality… 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Commercial Learning & Development, will be a key ... to understand training needs and translate into actionable and enriching associate learning curricula and fostering connections among commercial associates. This… 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
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... to lead and support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Clinical Development (GOCD) Functional ... management and implementation planning, for GOCD non-project related initiatives. The Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Merck & Co. (North Wales, PA)
- …Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible ... for independent compliance support of Medical Devices including the device constituent...Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post marketing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support… more
- Merck & Co. (North Wales, PA)
- …Vaccines Portfolio Marmeting Team, Integrated Account Management , Learning and Development, Clinical Review Teams, Legal and Compliance . In addition, this ... through the promotional approval process; requires collaboration with commercial legal, compliance and potentially multiple brand Clinical Review TeamLeading the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… 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. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and best practices as well as strong technical skills in working with ( clinical ) data. The position holder will require strong skills in continuous improvement, ... direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, policies,… more
