- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical ... monitoring team in review and interpretation of clinical data /medical protocol deviations in collaborations with the Clinical Director.Other responsibilities… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin our team as a Clinical Quality Operations Lead - Inspection Strategy and be at the forefront of developing and implementing policies, ... within and outside of GCTO to ensure that Good Clinical Practice Health Authority inspections are adequately supported and...mentor and develop staff within QCO, empowering them to lead and support regulatory GCP inspections.Insightful Data … 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
- Merck & Co. (Rahway, NJ)
- …enhance standards and associated processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards ... existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a… more
- Merck & Co. (North Wales, PA)
- …submissions) per regulatory requirements and industry guidelines.Ability to present clinical data clearly and objectively, with minimal supervision.Demonstrated ... clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer:Demonstrates independence in preparing clinical regulatory documents… more
- Eisai, Inc (Nutley, NJ)
- …to evaluate biomarkers across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this ... we want to hear from you. Job Summary The Senior Manager, Translational Science Biostatistics will be expected to...to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides… more
- Merck & Co. (Boston, MA)
- …community, research conducted in our laboratories spans exploratory biology through early clinical development and is an integral part of our company's powerful ... while advancing your career.Job Description:Our Company is currently seeking exceptional Senior Scientist peptide chemists to join our Boston site's highly… more
- Merck & Co. (Rahway, NJ)
- …our company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the ... Development Quality organization and for the company's R&D division.For company's Clinical Supply, act as the Quality Unit representative for information technology… 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 ... to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (South San Francisco, CA)
- …area's biomedical community, our research ranges from exploratory biology to early clinical development. We work on diverse modalities - small molecules, peptides, ... scientist for our Modeling and Informatics group. As a Senior Scientist (R3), you will be part of a...and deep learning to problems of biological interestExperience with lead identification and lead optimization of diverse… more
- Eisai, Inc (Nutley, NJ)
- …to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical education, research grants, ... provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He utilizes… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director, ... Engineering, Automation Lead position and will be a member of the...production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Merck & Co. (Rahway, NJ)
- …projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management, and other Company ... and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Merck & Co. (Rahway, NJ)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and ... project management experiences are necessary.Solid knowledge of statistical analysis methodologies, clinical trial designs, and statistical and data processing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leadership Product Evolution: Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...to experiment with us? The Position The Integrated TA Lead is instrumental in shaping and executing NNI's strategic… more
- Novo Nordisk Inc. (Boulder, CO)
- …network performance for data capture and analysis locally and globally. The Senior IT Engineer I - Labs will therefore be working closely with research and ... the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future,...you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) ... Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will...role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as… more
