- Eisai, Inc (Nutley, NJ)
- …for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai and ... co-marketing partner Safety offices, healthcare professionals and consumers to obtain and...to health care professionals, consumers, sales representatives, and other Safety staff for all marketed and investigational Eisai productsDesigns… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … manager . Uses medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal Evaluation: Assists manager in assessing new signals. ... centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current… more
- Aequor (Thousand Oaks, CA)
- Remote Copy of AMAGJP00012547 Scrubbed resume attached Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on ... on product teams (eg, Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) Provide functional area input for Global Regulatory… more
- Novo Nordisk Inc. (Durham, NC)
- …as well as internal stakeholders for the success of the Site. Relationships Manager , FUSE. Essential Functions Ensures all safety & environmental requirements ... a productive, engaging & safe working environment Manage any safety , quality, staffing or personnel issues & escalate to..., quality, staffing or personnel issues & escalate to manager as necessary Ensure documentation meets GMP requirements Lead… more
- Catalent (Manassas, VA)
- Scheduling ManagerPosition SummaryThe Scheduling Manager will work with the Site Leadership team and the extended functional leaders to take over the daily ... a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and...of our recruitment and on-boarding processes to maintain everyone's safety . The Human Resources teams will communicate all necessary… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare ... through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and ... within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and… more
- Merck & Co. (Durham, NC)
- …Ensure that maintenance activities are executed in compliance with Safety , Environmental and cGMP regulations.Investigate, determine root cause, and implement ... expert for LOTO and permit writing for maintenance activities, Safety Management Information Systems (SMIS) transactionsKnowledge of mechanical/electrical maintenance… more
- Merck & Co. (North Wales, PA)
- …finalization of all Supplier documents such as monitoring, project management, safety management, data management and validation plans.Participate in protocol and ... interim/final report preparation, shepherd documents through the internal review process for approval, and submit to the internal repository.Coordinate internal/external meeting management and draft/review agenda/minutes.Ensure studies follow all… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality support across programs ensuring GCP, GPV, GDP, and adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact ... Investigator initiated studies and Collaborative Research.Support adherence to regulatory safety requirements for all programs (ie post marketing, MAA requirements,… more
- Catalent (Manassas, VA)
- …help create engaging new products consumers will love.The Site Procurement Manager is responsible for procurement leadership, sourcing and procuring materials, ... services, and capital for the site. The Site Procurement Manager will lead site procurement team and initiate and...through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... maximize your potential with us? The Position The Product Manager is driven by a customer-centric mindset to meet...the development of new IT solutions. The IT Product Manager will be responsible for managing and overseeing the… more
- Catalent (St. Petersburg, FL)
- …a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Compliance Manager is ... Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... operates. The Manager , Supply Chain - Warehouse will lead a shift...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the highest integrity, focused on quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of ... regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety , CROs and External Vendors for the data services they provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...simultaneously Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Drive continuous… more
