- 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
- Merck & Co. (North Wales, PA)
- … clinical data /medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Merck & Co. (North Wales, PA)
- Job DescriptionWe are currently recruiting for the position of Associate Director , US Oncology - Hematology Scientific Strategy. This talented individual will ... a robust scientific leader (SL) engagement plan, coordinating with medical affairs, clinical research, and global marketing to provide a consistent One our Company's… more
- Merck & Co. (North Wales, PA)
- …of the role Preferred Experience and Skills: Ability to translate science/ clinical data into clear marketing strategies, medical education and/or ... including experience including bringing materials through legal, regulatory, and clinical review Strong project management skills as demonstrated by prioritizing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years Minimum 7 years' experience in life sciences, pharma with Clinical Trials Operational Data , Clinical Operational Metrics and Milestones. ... required4 or More Years Experience in working with CRO data for execution of large global clinical ...CRO data for execution of large global clinical trials. requiredSolid understanding of Metrics, KPIs, KRIs and… 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)
- …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)
- …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
- 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory ... Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting… 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)
- …robust publication plans for the Therapeutic Area and respective products. Mentor Associate Director Publication leads on publication planning and execution ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trials preferred- Demonstrated ability to leverage digital data and analytics preferred- Demonstrated ability driving or participating in digital ... procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of ...or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technology transfer, site-to-site technology transfers and PPQ as needed. Conduct data review and analysis, data -driven decision-making process, and support ... data transfer to the appropriate data repository - liaison between the Tech Strategy (...manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Associate Director , Clinical Operations...& study plans and other reports ie Protocol Deviations, Data entry & SDV status, Query status etc. and ... Sun Pharma Advanced Research Company Limited Princeton, New Jersey SummaryThe Associate Director , Clinical Operations is responsible for Oversight of the… more
