- Merck & Co. (North Wales, PA)
- …the development of the worldwide template document including global value dossier and input forms, design of data collection forms for customization to ... country specific HTA/reimbursement needs for the product and gain input on research design and implementation of retrospective database...as outlined in the OR planning process and generates data on a worldwide basis to support pricing and… more
- Novo Nordisk Inc. (Durham, NC)
- …& Subject Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts. Identify and share better practices, to include ... increasing awareness of data management standards & validation to create improvements in methods, techniques, approaches etc. for optimization & simplicity in our… more
- Aequor (Thousand Oaks, CA)
- …Expectation is 3 days onsite per week. The ideal candidate is a Data Scientist with a strong engineering background, preferably in Mechanical, Biomedical, or ... Chemical Engineering, with proven experience in simulation, modeling, and data analysis within a GMP-regulated environment. They are proficient in Python, MATLAB,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... role reports directly to the Vice President of Enterprise Data & Advanced Analytics (ED&AA) and serves as a...with the rest of the AI CoE and provide input for the vision and direction of AI product… more
- Genmab (NJ)
- …discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information ... in developing an integrated database specificationCDT member:Responsible for giving statistical input to overall strategy and the synopsis development in the… more
- Genmab (NJ)
- …discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information ... in developing an integrated database specificationCDT member:Responsible for giving statistical input to overall strategy and the synopsis development in the CDT… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, ... data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance...as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan… more
- Merck & Co. (Rahway, NJ)
- …regional execution, and the rollout to the countries, that guides TA scientific exchange ( input and output) and real-world data generation of all Research & ... a single global scientific communications platformDrives global, regional and key country expert input events (advisory boards and expert input forums) to answer… more
- Merck & Co. (Durham, NC)
- …compliance.- This is a fast-paced and multi-faceted role that provides leadership and input to every department on site across a wide range of business activities.- ... team success.SME support during routine internal and external GMP and Financial audits, input to QSAT actions, to ensure compliance.Support the Master Data team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... Oversight function in PV quality control processes, as well as providing SME-level input from the affiliate perspective when required. This role also provides direct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …KPIs/metrics to track process compliance, performance and adherenceWork with the data /systems SMEs to define reporting needs to oversee process performanceShare and ... review data /metrics with the GRA Analytics TeamCoordinate the development and...audits and inspectionsWork with QA to understand and provide input to the planned schedule internal audits and mock… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as the Point of Contact ... regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely registration of both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface ... factors with and for other technical departments (eg, Clinical, Medical, Safety, Data Management, Statistics). This position requires skills in working in a… more
- Merck & Co. (Durham, NC)
- …projected spend (Expense, Capital/Prepaid, and Product Cost as required). -Provide input into annual ExM Operations Profit Planning process.- Commercialization of ... visits, help determine equipment/facility investment requirements, and provide Operations input into Supply and Quality Agreements.- Launch Supply Risk… more
- Merck & Co. (Rahway, NJ)
- …integrity principlesCoach and mentor staff on analytical techniques, problem solving, and data integrity as needed.Share best practices across the company to enhance ... mindset.Exhibit exceptional leadership abilities and strong knowledge of cGMP and Data Integrity.Uphold strong values essential to fostering and contributing towards… more
- Merck & Co. (Rahway, NJ)
- …drivers and barriers to reimbursement and market access, and provide input into clinical, regulatory, payer/access, marketing and evidence generation strategy and ... authors study protocols, develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... other MPS teams and HR. External relationships include consulting partners, data providers and market research partners. Essential Functions Strategic Development o… more
- Eisai, Inc (Nutley, NJ)
- …medical affairs personnel to enter strategic and compliant discussions regarding medical/clinical data on Eisai products. The AD assumes a leadership role by ... initiatives including treatment landscape training (disease state and Eisai product data , pre-clinical data , experiential training, "special topics" training,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing ... to create and implement strategies that support launch. Provide medical support/ input into commercial and market access discussions for select indications.- Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing ... Local Country/Regional Medical Affairs activities when applicable. Provide medical support/ input into commercial and market access discussions for select… more
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