- Daiichi Sankyo, Inc. (Bernards, NJ)
- …early clinical safety for our Rare Disease/Specialty Medicine portfolio. SummaryThe Director , Clinical Safety, will be a product safety lead or part ... and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety… more
- Merck & Co. (Rahway, NJ)
- …accordance with US and WW regulations, company policies and standard operating procedures.The Senior Director of Clinical Supply Systems (CSS) is a key member of ... Job Description Position Overview - Basic Functions & Responsibility The Global Clinical Supply (GCS) organization, within our Research & Development Division, is… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at Eisai. This Executive ... budget planning & resource management.Demonstrated track record as Study Director (or equivalent role) with Global Clinical ...Study Director (or equivalent role) with Global Clinical Lead or Clinical Program Director… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical challenges in the ... be responsible for implementing new technological solutions for end users.The Associate Director , Clinical Programming manages and oversees JReview and SAS… more
- Merck & Co. (Rahway, NJ)
- …Atherosclerosis & Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire ... execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... office. Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is from :195,000-256,000Under current guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will ... collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… more
- Merck & Co. (Rahway, NJ)
- …Our company Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible for:Evaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- …Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May Be Responsible ForEvaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director Pulmonary Hypertension, Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) (referred to as EDMA) is ... Development Team, Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides a solid… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary:The Executive Director , Value & Implementation (V&I) Outcomes Research position resides in the V&I organization, which includes Global ... cross-functional teams is a critical part of this role. The Executive Director has scientific and budgetary oversight for all outcomes research activities conducted… more
- Merck & Co. (Rahway, NJ)
- …decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of ... pharmacometricians.The Director -Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating one or more of the following… more
- Merck & Co. (Rahway, NJ)
- …decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This Associate ... Director will work with scientists within QP2 by applying...PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into… more
- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As ... an Associate Director , you will represent QP2 on cr o ss-...sci e ntis ts to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and… more
- Merck & Co. (Rahway, NJ)
- …biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile Process ... Engineer role at the Associate Director level will leverage the individual's leadership, technical, and...and communication skillsets to drive the success of our clinical manufacturing facility and organization. As the facility is… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Overview - Basic Functions & Responsibility The Global Clinical Supply (GCS) organization is within our Research and Development division ... and is accountable for managing the 'end-to-end' integrated clinical supply chain across our Research & Development division portfolio to enable the execution of any… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryThe Associate Director , Global Scientific & Value Content-Healthcare Professional (AD, GSVC-HCP), position resides in the Value & ... content strategy and plans with other V&I partners, such as Publications, Clinical and Outcomes Research. Aims to ensure the timely availability of effective… more
- Merck & Co. (Rahway, NJ)
- …barriers to reimbursement and market access, and provide input into clinical , regulatory, payer/access, marketing and evidence generation strategies and programs.In ... Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers.Develop supplementary clinical data package in close partnership with markets and HTA statistics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signaling detections and across compounds safety reviews (ie, ILD). Collaborate with Clinical Development and Clinical Sciences for effective data surveillance ... knowledge of all aspects of the R and SAS programming language used in clinical trials programming. required- Advanced working knowledge of CDISC SDTM and ADaM, and… more
