- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Genmab (NJ)
- …to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight ... to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to...and authentic is essential to fulfilling our purpose.The Role:An Associate Director , Data Management is operationally responsible… more
- Insmed Incorporated (Chicago, IL)
- …industry, come to Insmed to accelerate your career.RecognitionsConsistently Ranked Science 's Top EmployerInsmed is dedicated to creating a collaborative environment ... where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named… more
- Genmab (NJ)
- …(including clinical trial implementation, and oversight of all aspects of clinical development) working closely with the Medical Director and other ... to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to...clinical development plan (CDP) Author components with Medical Director and reviewer of clinical and regulatory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... supporting the pharm and vaccine veterinary clinical trials. The ideal candidate will be responsible for overseeing the development and maintenance of clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong… more
- Genmab (Plainsboro, NJ)
- …caring, candid, and impact-driven to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to be our best, and ... authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a single or multiple … more
- Merck & Co. (Rahway, NJ)
- …the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance ... Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of clinical … 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 ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Oncology Regional Medical Scientific Director ( Associate RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and ... policiesMaintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI)ResearchUpon request… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to...the relationships with the clinical vendors as well as coordinate and manage outsourcing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs ... from early research through late-stage clinical development. We are building for the future, creating...difference? The Position We are seeking a collaborative and science -driven global regulatory expert who wants to work with… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development ... to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to...Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Merck & Co. (Lower Gwynedd, PA)
- …Us: The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late ... facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... global sites. These business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study… more
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