- Merck & Co. (Rahway, NJ)
- …cost/size, number of trials, clinical trial design and Go/No Go decisions- Serve as a subject matter expert and foster collaboration within QP2 and across ... above duties and to develop the above capabilities Leverage significant pharmacometrics and subject matter expertise in a broad range of therapeutic areas,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … data cleaning needs for DS Programs / Studies.Serve as the subject matter expert for Study Data Managers during the planning/start-up, conduct and ... (QCP, Clinical Biomarkers, etc.) Clinical Safety, CROs and External Vendors for the data services they provide to support drug development processes and global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …defined analysis endpoints (primary, secondary, etc.) thereby serving as a subject matter expert for all external data management business needs. This ... safety and pharmacovigilance, CROs and External Vendors for the data services they provide to support drug development...requirements are met. Serve as the subject matter expert to data management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Maintains current knowledge of industry best practice in AI/ML methodology- May act as Subject Matter Expert for AI/ML by providing guidance and support ... end-to-end delivery of AI/ML projects (from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time… more
- Merck & Co. (Rahway, NJ)
- …across our Company's commercial digital marketing division for Global stakeholdersAs subject - matter expert in commercial analytics data domains, you will ... Job DescriptionPosition Description: Associate Director Data Product Management Job Description We are seeking a strong, highly energetic and collaborative leader to… more
- Lundbeck (Bothell, WA)
- …SOPs, development reports, and technical reports In partnership with QC, serve as the Subject Matter Expert ( SME ) in the transfer of analytical ... QC (as needed) with method transfers, qualifications and validations and ultimately serving in a Subject Matter Expert role. Key to the position is a… more
- BioAgilytix (Durham, NC)
- …from initiation through delivery.Trains users on the use of automated systems. Serve as subject matter expert ( SME ) for select laboratory systems ... and existing business needs. This position serves as an Automation Expert , ensuring the efficient operation of automated laboratory equipment, conducting… more
- Merck & Co. (Boston, MA)
- …candidate will lead PDMB efforts as a project-team representative and PK/PD subject matter expert , regularly interacting with multi-disciplinary discovery ... this exciting position, your primary roles will include:Project-team representative and subject matter expert on protein therapeutic-based PDMB… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter expert ( SME ) to support ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and competency of the ... with the FDA to providing medical education and collecting data to support efficacy and new product development...areas of opportunity aligned with Therapeutic Area priorities Utilizes subject matter expertise and analytical tools to… more
- Merck & Co. (Rahway, NJ)
- …the strategic elements of drug development and effective communication skills. As a subject matter expert , the Associate Director within the Group will ... an aligned, quantitative framework to impact strategies and decisions on drug development teams. Primary Responsibilities: Serving as an expert representative… more
- Merck & Co. (North Wales, PA)
- …of resources, professional- development , and performance management.May serve as a subject matter expert and/or participate on process improvement ... medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical Director.Builds talent and… more
- Eisai, Inc (Raleigh, NC)
- …(where applicable), industry standards and internal company policies.Applies knowledge and experience as a Subject Matter Expert ( SME ) across and beyond ... and oncology, with a strong emphasis on research and development . Our history includes the development of...see the big picture and assess the impact of data and/or decisionsTravel (domestic and global) 40% or more… more
- Tris Pharma (Monmouth Junction, NJ)
- …evaluate and communicate safety observations. The incumbent functions independently as a subject - matter expert ( SME ) while working collaboratively ... privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from sites/ Institutional Review Boards (IRBs), and other site personnel as needed- Study-specific subject matter expert (ME) for internal audit or Health ... disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, execution,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus on budget, quality, compliance and in alignment with business needs Serve as a subject matter expert on key policies and processes related to ... with the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us… more
- Merck & Co. (Rahway, NJ)
- …monitoring issues for efficient project management and timely resolution. Act as a subject matter expert , offering direction, education, and assistance to ... experience to lead engineering design, prioritize tasks, and collaborate with development teams, ensuring scalability and security. Your expertise will be crucial… more
- Merck & Co. (Rahway, NJ)
- …including prefilled syringes, auto-injectors, on-body infusers/injectors, inhalers, and more. As a subject matter expert in medical device and combination ... developing tailored testing strategy for unique combination products? Join our Company's Device Development team as Senior Engineer or Senior Scientist and be at the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and competency of the ... with the FDA to providing medical education and collecting data to support efficacy and new product development...areas of opportunity aligned with Therapeutic Area priorities Utilizes subject matter expertise and analytical tools to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of new technology/equipment as needed Supervises and mentors microbiology team Technical subject matter expert on microbiological assays, techniques and ... industry practices Participates in the review of microbiological trending data and writing reports to summarize trends Investigates and resolves issues related to… more
