- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... & Deployment 30% Manage financial aspects for projects including development and review of SOWs, purchasing, budgeting, and budget review for projectsDevelop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Medical Affairs (GMA) Oncology- Medical ... for execution of global scientific and training deliverables. The Associate Director develops and executes Medical...by Regional Medical Science Liaisons Oversee comprehensive medical review and clearance of materials/programs as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… 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 ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...test plans to ensure all requirements have been met. Review integration test plans and perform integration testing as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... QA relevant activities including QQR, monthly quality report, team building and management review .- Involve and attend the Global QA relevant meeting and create the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating ... minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Qualifications: Successful candidates will be able to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMACompetencies:Advanced knowledge… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal stakeholders ... include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management,...Global Safety Lead(s), Global Safety Lead(s) and Global Safety Scientist(s)/ Associate within Safety Surveillance. Essential Functions Innovation and change… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …key functional areas of the organization in the planning, submission, review and approval, distribution and lifecycle management of promotional marketing materials. ... guide the successful completion of promotional initiatives. Relationships Reports to Director , Marketing Operations. Primary interaction is with teams that submit… more
