- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... Works with management to maintain the consistent execution of quality global procedures. If applicable, monitors workload and resource...are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a … more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Our ... Clinical Research and Pharmacovigilance team push the boundaries of...for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.Contributes to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... excellence in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops ... Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Essential Functions Executes all relevant services/tasks in support of the planning and quality delivery of clinical trials in line with established targets and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Catalent (San Diego, CA)
- …Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational Excellence,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the ...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol ... opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of… more
- Aequor (Piscataway, NJ)
- Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule: West Chester.PA (hybrid) Is this temp to perm? The manager intends to convert the ... FTE after a year Shift Type: Day M-F 9-5 Position Summary: The Manager /Sr. Manager , Medical Communications (S/MMC) supports publication strategy and plan… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(eg, clinical overviews, formulary dossiers, online evidence repository) Performs quality assurance review of after-hours calls handled by vendor and serves as ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Lundbeck (New York, NY)
- …the way in creating positive customer experiences!As a Biopharmaceutical Area Sales Manager (BASM) you will be responsible for leading, developing, and managing a ... Others Achieves business objectives and sales results by observing Account Manager interactions with target customers, extended treatment team members, ancillary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It ... programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, perform… 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 ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes… 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 ... within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality ...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of ... is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes… more
- Aequor (Thousand Oaks, CA)
- …of a driving range of Thousand Oaks. Some qualities that stand out to the hiring manager on resumes is: Looking for candidates who can be viewed as the top end of ... hands off leader, candidates who have familiarity with Pharma; Clinical Trials. Qualities an ideal candidate possess that will...ability to do the right thing (ethics). The hiring manager needs a candidate with the ability to be… 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 foster relationships with site stakeholders,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …[QMS] QA, PV/MA Quality ) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ensure ... in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD business process owners that… more
