- 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)
- …veterans and people with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership ... with Clinical Safety Scientist Product Lead, Product Safety Lead...Lead and PSL - May serve as a project manager for other activities involving assigned product(s) or clinical… 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. Summary Position supports safety monitoring and risk management activities, provides insights on current clinical… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... with a team of individual contributor production direct reports including safety , quality, and daily operations;Ensure that Shift(s) objectives are achieved while… 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
- 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 ... ready to maximize your potential with us? The Position The Senior Manager , Commercial Insights & Analytics, provides insights and analytics expertise, primarily… 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
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... tours to provide area/process overview information to visitors/auditors upon requestQuality & Safety ComplianceFoster strong and effective safety culture on the… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of... to create and sustain a site culture of Safety , Quality performance, Operational Excellence, continuous improvement, error reduction,… 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
- 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
- Merck & Co. (Rahway, NJ)
- …through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, ... to address and resolve issues, with minimal support from the Sr.COM or manager .Ability to make decisions independently with limited oversight from Sr.COM or … more
- Novo Nordisk Inc. (Boulder, CO)
- …NN TRU Boulder facility complies with all applicable environmental, health and safety regulations. Relationships Reports to Senior Specialist EHS at US headquarters ... valued vendors. Essential Functions Manage the maintenance and implementation of safety programs, compliance plans, and initiatives with primary focus on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …oversight and management of all contract and vendor related activities in Patient Safety including, but not limited to, contract review and vendor management support ... in regards to safety reporting. To serves as a liaison between NNI Patient Safety Group and other departments on Safety Data Exchange Agreement (SDEA)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... o 21 CRF 11: Electronic Records, Electronic Signatures o 21 CFR 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse… more
- Aequor (Framingham, MA)
- …monitoring, and participating in the development of site health and safety programs (Ergonomics, Laboratory and Chemical Safety , Bloodborne Pathogens, ... compliance with all applicable federal, state, and local occupational health and safety regulations and permits (Occupational Safety and Health Administration… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships include Medical & Scientific Affairs, Field Medical Affairs, Product Safety , Customer Care, Sales, and Marketing. Essential Functions Provides verbal, ... written, and on-demand video responses to unsolicited medical and technical inquiries about Novo Nordisk products from HCPs, institutions, and/or payors Creates and/or revises standard and custom medical information responses for use in responding to existing… more
- Merck & Co. (Rahway, NJ)
- …by setting priorities (in agreement with line function & Project Manager ).-Ensure availability of regular reports concerning results, costs, budgets and provide ... updates (line function and Project Manager ) routinely.-Ensure an overall high quality of development work...areas of Good Laboratory Practice, business conduct, and general safety .-BACKGROUND REQUIREMENTS: ( M ini m um academic credentials… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for ... on product teams (eg, Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) Provide functional area input for Global Regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to resolve issues. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Require minimal direction to complete ... tasks, know how to get resources and information from established internal contacts, and consult with supervisor for decisions outside established processes Requirements A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical… more
