- Merck & Co. (Rahway, NJ)
- … Associate Director will:Provide financial planning, forecasting and analytical support to our Research Department Therapeutic Area Clinical ... the R&D engine that drives our Company's biopharmaceutical business.Position Description: Associate Director, Finance Clinical Development Finance (CDF) is… more
- Novo Nordisk Inc. (WA)
- … support role and responsibilities Drives recruitment and retention strategies to support clinical trial sites to meet country enrollment and retention ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved.… more
- Merck & Co. (Rahway, NJ)
- …team members including clinical directors and study managers to lead/ support clinical trial scientific activities in the Atherosclerosis & Metabolism ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead,...TA.Job ResponsibilitiesResponsible for the clinical /scientific execution of clinical protocol(s). Serves as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/ Metabolism Section Head in the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical ... individual will be responsible for overseeing Product Development Team Leaders and- Clinical Directors within their group to ensure successful execution of programs… more
- Novo Nordisk Inc. (Omaha, NE)
- …Networks (IHNs), and Health Economics & Outcomes Research (HEOR), as needed Field-based clinical support : Communicates clinical account strategies to NNI ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Principal Statistical Programmer - Oncology (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a ... programming analysis and reporting deliverables for global stakeholders. The Associate Principal Programmer will gather and interpret user requirements for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor… more
- Merck & Co. (North Wales, PA)
- …and high-quality data to support decision making in clinical trials.-The Associate Principal Scientist, Statistical Programmer supports the ... and develop complex programming algorithmsProvide technical consultation and analytical support to statistical programmers and statisticiansRepresent our Company on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved....you ready to make a difference? The Position The Associate Director of Medical Data Strategy and Analytics plays… 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, ... responsible for providing needed support and direction to other staff/contractors on these programs....incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Merck & Co. (North Wales, PA)
- …Responsibilities :Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development ... Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and other company Research Laboratories Scientists in designing and… more
- Aequor (MA)
- …review and approval on SOPs, forms, WI, and other document types. Provide SAP support for GMID and BOM approval. Provide Quality oversight and Quality guidance to ... of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials....Quality Risk Assessments Assist with internal and external audits. Support of data analysis and metrics for Quality Council,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The ... and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory… 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. (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 ... practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve as the liaison and manages correspondence with… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and ... labeling and labeling trends, proposing content as relevant to support optimized labeling. Ensure proper development, review, approval, implementation, maintenance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... the Health Authority (eg, US FDA and EU EMA) for assigned projects with support , on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2,… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager, you will be in the Statistical Programming team ... leading a small team to complete various programming efforts within a clinical trial.You will be responsible for ensuring integrity, consistency, and adherence to… more
- Merck & Co. (North Wales, PA)
- …is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes ... statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and… more
