- Merck & Co. (Rahway, NJ)
- …including Global Project and Alliance Management, Product Development Team (PDT) Leaders, and Clinical Study Managers regarding study budgets, site and ... toolkit beyond standard P&L analytical approaches, including big data analysis, clinical studies , partnerships and collaborations management, and resource… more
- Novo Nordisk Inc. (WA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability;… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the Program Lead, you will ... collaborate with global, cross-functional team members including clinical directors and study managers to lead/support clinical trial scientific activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study Strategy: Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product(s) or clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and build and review Statistical Analysis Plans (SAPs) and ... development of minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs), for assigned… more
- Merck & Co. (North Wales, PA)
- …potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical-analysis and high-quality ... data to support decision making in clinical trials.-The Associate Principal Scientist, Statistical Programmer supports the design, development, and delivery of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document… more
- Genmab (Plainsboro, NJ)
- …as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and ... be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development… more
- Merck & Co. (Rahway, NJ)
- …Metabolism projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study ... Job DescriptionThe Associate Vice President (AVP)/ Metabolism Section Head in...and to ensure optimal trial design and monitoring of studies , producing high-quality clinical documents and presentations.… more
- Merck & Co. (North Wales, PA)
- …teams for the strategic planning and execution for product development-Is involved in clinical development planning to ensure that study designs are consistent ... program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Eisai, Inc (Jersey City, NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director, Medical Writing will be the designated Lead Medical Writer for multiple Programs, ... writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Novo Nordisk Inc. (Omaha, NE)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Affairs (FMA), this position has primary responsibility for directing clinical engagement efforts and developing/implementing medical account strategies on behalf… more
- Merck & Co. (North Wales, PA)
- …the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates...product labeling as it relates to the use of study results in US promotion.Maintain current awareness of evolving… more
- Genmab (Plainsboro, NJ)
- …Director, Programming.Key responsibilities include:Supports and/or leads programming efforts within a clinical study , depending on background and experience.As a ... essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager, you will be in the Statistical Programming team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study ... protocolProficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global regulations preferredGood knowledge of Good Documentation PracticesEffectively manages shifting priorities;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendors. Supports regular vendor/sponsor discussions to identify risks and ongoing study support. Identifies critical issues which may compromise patient dosing or ... and approvals. Support regular vendor/sponsor discussions to identify risks and ongoing study support.Ensures on time site shipments for subject and patient dosing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of all clinical and nonclinical documents for submissions, eg, clinical protocols and study reports, preclinical reports, investigator brochures, application ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor selection criteria.- Problem solves and negotiates in most service types, studies , and programs- Responsible for the development and management of other ad ... preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement… more
- Merck & Co. (Rahway, NJ)
- …real-world evidence data generation and coordinates local data generation studies with V&I Outcomes ResearchSupports the Investigator-Initiated Study ... and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director, Value & Implementation (referred to as EDMA) engages… more
