- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... subsidiaries in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... and external network Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities Provides...visits at any time during the conduct of the study to provide medical input- Provides medical guidance for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for developing the ... management from a medical perspective -Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and planning alignment across the matrix team consisting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or project; Attends EOP2 meeting and represents clinical/TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational study ... Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies ...Study Team (IST) representative or IST leader on study team; Responsible before senior management for… more
- Eisai, Inc (Nutley, NJ)
- …across programs, as well as the study statistician for clinical studies . As the statistical lead for biomarker development, this individual primarily ... is your profile, we want to hear from you. Job Summary The Senior Manager, Translational Science Biostatistics will be expected to work independently with minimal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …meeting and represents clinical/TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational studies ; Develop prospective ... communication and decision-making process cross-functionally and cross-regionally; Facilitate team coordination. Study Outputs: For Phase 3 studies : Drafts… more
- Merck & Co. (Rahway, NJ)
- …testing strategy for unique combination products? Join our Company's Device Development team as Senior Engineer or Senior Scientist and be at the forefront of ... in medical device and combination product design verification, the candidate will lead the strategy and execution of design verification activities from concept to… more
- American Honda Motor Co Inc (Marysville, OH)
- …our team to Bring the Future!Job Purpose As the Talent Acquisition Reporting Lead , you will spearhead the reporting team, driving the delivery of robust reporting ... gaps, trends, and overall effectiveness of the recruitment function. Lead and own detailed analysis to assess data quality...Science, Statistics, Data Science, or other related field of study or equivalent knowledge and experience 5+ years of… more
- U of C NORC (Chicago, IL)
- …corporate indirect expenses.Provide accurate, timely, and useful financial analysis for senior leadership. Lead and effectively work with cross-functional teams ... in data collection, program evaluation, data analysis, and information dissemination, seeks a Senior Financial Analyst II to join the Corporate Finance team. The … more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Medical Writer is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With ... minimal oversight, the Senior Medical Writer:Demonstrates independence in preparing clinical regulatory documents (eg, protocols, clinical study reports,… more
- Merck & Co. (Rahway, NJ)
- …(CRO) and external statistical consultants.This position may serve as a statistical lead in project teams.The incumbent may initially work in a specific disease ... qualified statisticians.Directs biostatistical support required for assigned projects.Serves as lead statistician in cross-functional teams for the strategic planning… more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... clinical regulatory documents and submissions for own area of study / program/ marketing application, with directionExperience managing multiple projects by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director, Global Oncology Medical Affairs, Evidence Generation role is ... of working in collaboration with a strategic alliance partner.Responsibilities- Co- lead a cross-functional Evidence Generation Team (EGT) for the assigned… more
- Lundbeck (Bothell, WA)
- …Lundbeck Biopharmaceuticals is seeking a highly motivated and experienced individual to lead the Potency Assay group supporting the development of novel therapeutic ... ensure successful method validation at contract labs/CMOs; support investigations and lead troubleshooting efforts as required Prepare and qualify cell banks… more
- Novo Nordisk Inc. (Durham, NC)
- …Management (Mdev LCM) in Emerging Technologies (ET) for the production site. Lead strategic activities ensuring new products can thrive without disrupting the ... and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead , drive & coach teams to ensure a high performing collaborative… more
- Novo Nordisk Inc. (Boulder, CO)
- …reduce risk and cost to the overall operation. Relationships The Technical Team Lead , API Manufacturing reports to the Senior Manager, API Manufacturing. The ... to make a difference? The Position The Technical Team Lead , API Manufacturing works in Novo Nordisk's Boulder, Colorado...the production of non-cGMP oligonucleotide API to support toxicology studies . In addition to ensuring the supply of API… more
- Eisai, Inc (Nutley, NJ)
- …therapeutic area. Communicate and represent these plans to upper management/ senior leadership. Continuously update plans and inform stakeholders of progress.She/He ... will lead medical strategy mainly for GU oncology and provide...the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory guidance regarding… more
- George Washington University (Washington, DC)
- …and community engagement by fostering forward-thinking and inclusive leadership skills. The Senior Academic Advisor will lead two sections per semester of ... of this mission, the GWSB Undergraduate Programs Office is searching for a Senior Academic Advisor. This individual is a key contributor to developing forward… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clin pharm patient studies , and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... as well as programs or franchises.When sitting on a study team, lead the study ...Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population ... teams.ResponsibilitiesResponsible for all aspects of clinical pharmacology and biopharmaceutics studies ; clinical pharmacology project lead ; supports Phase 2/3… more
