- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... 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. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... global sites. These business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study… more
- Genmab (Plainsboro, NJ)
- …caring, candid, and impact-driven to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to be our best, and ... authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a single or multiple … 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
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to...the relationships with the clinical vendors as well as coordinate and manage outsourcing… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development ... to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to...Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . **Description** : In support of Commercialization Strategy, the Associate Director of Commercialization Data Science & ... pioneer new machine learning solutions, improved ways of applying data science to drive value, sophisticated solution designs and cutting-edge modeling capabilities… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Ensures trial master file is complete and accurate for assigned stud(ies). + If assigned, Associate Director , Clinical Operations may act as the Study Team ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Summary:** Join our People Science team as our next Associate Director , Employee Listening Lead, where you'll play a crucial role ... in transforming patients' lives through science by enhancing our workforce strategy through the power...unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation,… more
- AbbVie (Branchburg, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Clinical Development will have global or ... position may be based in Branchburg, NJ or Irvine, CA. Responsibilities: The Associate Director will be responsible and accountable for the development,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving global ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in Cambridge, ... the Pharmacovigilance Operations team, you will report to the Director , PV Clinical Operations and will be...compliance + Liaise with and advise study teams including Clinical Science , Data Management, Regulatory Affairs, and… more
