- 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)
- …including veterans and people with disabilitiesSummary 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
- Catalent (New York, NY)
- …as assigned.The Candidate Proven, successful track record as sales executive or brand manager in a leading company operating in the cosmetic industry, minimum 3 ... 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... operations team for the site.- The Manager will direct a team of hourly personnel who...embraces our team culture including significant interaction with operations, safety , automation, and other groups as necessary. This Position… 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
- 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
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …Facilitate Project Steering Committees in collaboration with Business Owner and Project Manager . Represent business needs to the broader EIT organization such as ... Architects and IT Operations. Partner with ITQA, Business Owner and IT Project Manager for defining a master validation strategy where applicable. Partner with R&D… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, ... Data generated at site are complete, accurate and unbiasedo Subjects' right, safety and well-being are protectedConducts site visits including but not limited to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(AESI) educational materialsThis role works cross-functionally to collect / update safety and treatment information that is ultimately provided to educate patients ... consulting experiencerequired and - Prior work experience as a project manager , project lead, or similar role within pharmaceutical drug development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the data services they ... and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as...as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical development plans, and addressing all regulatory, drug and patient safety , data, CMC, IP, patient selection, market acesss and and other relevant ... processes.Providing proactively regular strategic and tactical status updates to their manager and governance on progress, risks, opportunities and challenges, and… more
- MTA (New York, NY)
- Senior Manager Safety Job ID: 4281 Business Unit: MTA Construction & Development Location: New York, NY, United States Regular/Temporary: Regular Department: ... 30 days after their effective date of hire. JOB TITLE: Senior Manager , Safety AGENCY: Construction & Development DEPT/DIV: Delivery / Systems REPORTS TO:… more
- MTA (New York, NY)
- Assistant Manager Safety Job ID: 5598 Business Unit: MTA Construction & Development Location: New York, NY, United States Regular/Temporary: Regular Department: ... 30 days after their effective date of hire. JOB TITLE: Assistant Manager Safety AGENCY: Construction & Development DEPT/DIV: Delivery /Various REPORTS TO: … more
- MTA (New York, NY)
- Manager Safety Job ID: 3086 Business Unit: MTA Construction & Development Location: New York, NY, United States Regular/Temporary: Regular Department: MNR Date ... to apply 30 days after their effective date of hire. JOB TITLE: Manager Safety AGENCY: Construction & Development DEPT/DIV: Delivery / MNR REPORTS TO: Assistant… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …of safety topics for products working closely with Drug Safety Global Safety Team (GST) Chair (Medical Director). The Manager , Drug Safety will ... and for potential safety signals, and author safety aggregate reports as needed. The Manager ,...author safety aggregate reports as needed. The Manager , Drug performs medical analyses for risk characterization to… more
- Port Authority of New York and New Jersey (Jersey City, NJ)
- …positions and superior interpersonal and communication skills to serve as its General Manager , Agency Safety Management. Reporting to the Director, Health and ... Safety , the General Manager -Agency Safety Management will oversee and provide leadership to the Agency Safety Management Division of the Office of the… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Manager , Drug Safety Aggregate Reports will function as the overall project ... for the development and finalization of assigned key safety documents such as Development Safety Update...assigned key safety documents such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports… more
