- 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
- 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
- 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
- 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
- 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
- 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)
- …systems. Manage the development and oversight of site operations through data analytics.Establish and monitor key performance indicators (KPIs) for HVAC system ... managing operating expense within approved budget.Identify capital projects and provide technical input to the development of HVAC site utility master plan and… 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
- Merck & Co. (Millsboro, DE)
- …and ensure employees meet or exceed current procedures and techniquesCoordinate SAP and data base entry and the movement of finished good and in-process products ... for our continuous improvement program.Lead Tier 1 communication meetings and provide input into Tier 2 and Tier 4 level meetings.Minimum Education Requirements:… 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
- Merck & Co. (South San Francisco, CA)
- …design, protocol development, study execution, reporting and interpretation of data . Maintain a comprehensive understanding of global regulatory expectations and ... documents and submissions. Work closely with pharmacometrics team members and provides input related to analysis and reporting of modeling activities. Required: A… more
- Merck & Co. (North Wales, PA)
- …drivers and barriers to reimbursement and market access, and provides input into clinical, regulatory, payer/access, marketing and evidence generation strategies and ... study protocols; and develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and… 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 ... function in PV deviation management processes, as well as providing SME-level input from the affiliate perspective when required. This role also provides direct… 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 ... the PV Oversight for NNI Patient Safety processes and as providing SME-level input from the affiliate perspective when required. This role also provides direct… 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
