- Legend Biotech USA, Inc. (Raritan, NJ)
- …procedures across the validation lifecycleAlign global documentation strategyProvide input and review for validation documents including master plans , PPQ and ... dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day...short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital… more
- Insmed Incorporated (San Diego, CA)
- …scientist(s), medical monitors, and drug safety to provide support and scientific review of safety data and study plans Support corporate objectives:Development, ... teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plansContribute to scientific and… more
- Insmed Incorporated (NJ)
- … review of adverse events and related safety data.Provide scientific review of statistical analysis plans , applicable study committees charters, and ... Collaborate with internal teams, CROs, and external vendors to prepare, review , and finalize clinical protocol documents.Contribute to scientific and operational… more
- Eisai, Inc (Boston, MA)
- …defined objectives and goals within assigned regional payer accounts while building a strong corporate presence with key decision-makers, thought-leaders, and ... Executives to work with downstream regional payer accounts of the national payers. Review and analyze applicable data to make informed decisions on regional payer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices ... (GDP). Review , revise, or draft Standard Operating Procedures (SOPs)Support processes...dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the company's primary contacts/advocates responsible for developing strategic lobbying plans , as well as communicating and promoting the company's positions ... contract lobbyist responsibilities and directs activities in order to execute action plans designed to maximize Novo Nordisk's impact on policy makers and patients,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure their direct reports are delivering to agreed upon study plans , properly identifying risks/mitigations, escalating as appropriate and utilizing data and ... metrics to put appropriate strategies and plans in place as well as measuring the status/variance...Clinical Operations quality and metrics. IT will also include building and sustaining relationship with key stakeholders to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory data.Utilize electronic systems (LIMS) for execution and ... documentation of testing.Create, review and approve relevant QC documents, SOP's and WI's.Perform...informed decisions quickly.Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has… more
- Insmed Incorporated (NJ)
- …oversight on multiple projects simultaneously. Author CSV Documents (Validation Plans and Summary Reports) Assist/co-author requirements, testing, specification, and ... project team members on CSV projects ensuring team members follow laid out CSV plans Provide real-time oversight and support during test execution and review … more
- Novo Nordisk Inc. (Spokane, WA)
- …to interpret and analyze data, generate insights and develop a business plan across multiple therapeutic areas (TAs) Develops and oversees key customer relationships ... high-impact behaviors to drive the sustainability of the business Executes plans around market trends and competitive dynamics Consistently drives exceptional… more
- Novo Nordisk Inc. (Boulder, CO)
- …change management, planning/organizing & managing execution required Demonstrated ability to review complex organizational plans & provide any required or ... continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on… more
- US Customs and Border Protection (Cameron Park, TX)
- …see if you are interested in these federal law enforcement opportunities and review the qualifications section below to see if you are qualified. IMPORTANT NOTICE: ... of federal employment benefits that include health and insurance plans , a generous annual and sick leave program, and...sick leave program, and participation in the Thrift Savings Plan , a retirement plan that is similar… more
- AUROBINDO (Durham, NC)
- …and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an ... IPQA (In-Process Quality Assurance) functions during IPQA absences.ResponsibilitiesCoordinate production priorities. Review IPQA entries in batch records on the floor.Assist… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for ... within the siteReview and approve qualification/validation documentation (specifications, protocols, reports). Review and approve periodic review documentation for… more
- Merck & Co. (Virginia Beach, VA)
- …with key stakeholders to understand practice structure, and business model, while building business relationships and trust to uncover and comprehend their needs.In ... drug distribution (Oncology group purchasing organizations, wholesalers, and specialty pharmacies). Review and evaluate patterns for products purchased and prescribed… more
- Insmed Incorporated (San Diego, CA)
- …stakeholders and project team members. Author CSV Documents (Validation Plans and Summary Reports) Assist/co-author requirements, testing, specification, and other ... Gdoc. Etc.) Provide real-time oversight and support during test execution Review executed protocols and provide test protocol deviation assessment and resolution… more
- Insmed Incorporated (NJ)
- …on Insmed therapies. This role involves developing and executing strategic plans for production, packaging, distribution, and clinical supply budgeting. The Director ... strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and continuous improvement reviewsEstablish and maintain KPIs,… more
- Insmed Incorporated (NJ)
- …data generation strategy including gap analysis, to evolve product data generation plans and ensure there is OneMedical strategy. Review publications, help create ... company strategy and there is cross functional alignment.Development and execution of MA plans : ensure that strategy is reflected in medical plans and that… more
- Insmed Incorporated (NJ)
- …and reviews of validated systems. Author CSV Documents (Validation Plans and Summary Reports) Assist/co-author requirements, testing, specification, and other ... project team members on CSV projects ensuring team members follow laid out CSV plans Provide real-time oversight and support during test execution and review … more
- Insmed Incorporated (NJ)
- …ongoing and planned trialsDevelops and manages detailed project and other trial-related plans and documentation and provides regular study status updates to senior ... Indication/Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings.Proactively identifies potential resource… more
