- 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 ... - Leadership, Direction, and Strategy:Leads implementation of Therapeutic level clinical data collection requirements including cross-functional standards… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Medical Affairs Omnichannel Engagement, role is to support the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and governing the medical affairs omnichannel engagement strategy. The Associate Director - MOE will work with one… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …applications and best practices as well as strong technical skills in working with ( clinical ) data . The position holder will require strong skills in continuous ... understanding and translation of business needs to AI/ML tasks, over data understanding and preparation, to modeling, validation and dissemination- Identify… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, and coding library management.Manages, reviews and approves medical coding of clinical data ensuring high quality; creates and manages the ... immune disorders. Summary Position manages the end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... of submissions and identify deficiencies against regulatory guidance's or internal data bases.- Facilitate and support liaison activities with functional groups… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP...virtual population workflow is desirableExperience with general programming and data analysis tools/languages such as Python or R would… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities ... and lead discussions as a functional expert on:- Newly available clinical data and promotional content within the assigned therapeutic area- Regulatory… more
- Merck & Co. (Rahway, NJ)
- …to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… 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
- 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...information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing… 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 ... pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the...members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and… 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 ... device/combination product documentation to support regulatory filings and audits of data , policies, procedures, and systems to ensure compliance with Medical Device… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other ... development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Phase 1 studies and multiple dose scenarios, PK/PD M&S analysis data structures and analysis tools requirements, simple disease models, regulatory guidelines ... in pharmacology or pharmaceutical sciences or PharmD with a clinical pharmacology research fellowship required Experience Qualifications 1+ years Industry… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
