- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:The Associate Director, Medical Review Committee (MRC) Operations is responsible for managing the operational execution ... of the company's Global We're looking for an Associate Director, Medical Review Committee Operations, on the Medical Review team to help us expand what's… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reconciliation.Shift Schedule: Wed-Sat, 1st ShiftKey ResponsibilitiesServe as a Document Control reviewer for new and revised procedures and documents to ensure ... users with workflow handling and electronic system usage.Manage the periodic review process for procedures.Issuance of batch related documentation in support of… more
- 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
- Charles Schwab (Westlake, TX)
- …the United States on a full-time basis without employer sponsorship. Schwab Stock Plan Services (SPS) within Workplace Services (WS) provides a variety of solutions ... public and private companies for the administration of their Equity Compensation plans , including stock options, restricted stock, employee stock purchase programs,… more
- Charles Schwab (Austin, TX)
- …the United States on a full-time basis without employer sponsorship. Schwab Stock Plan Services (SPS) provides a variety of solutions to large, publically traded ... companies for the administration of their Equity Compensation plans , including stock options, restricted stock, and employee stock purchase programs. SPS offers… more
- Insmed Incorporated (San Diego, CA)
- …internal teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plans Contribute to ... design planning through final reporting of results Provide scientific input and review of clinical study data, support in assessing medical monitoring reports, study… more
- Eisai, Inc (New York, NY)
- …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
- Insmed Incorporated (NJ)
- …perform medical assessment of individual adverse event reports generation; and review aggregate reports and safety documents, including labeling changes.What You'll ... Insmed's portfolio of products in development. You'll also:Be responsible for appropriate review of all safety data from various sources (eg pre-clinical, clinical… more
- Pfizer (Groton, CT)
- …to establish, lead, coordinate, and execute the early oncology clinical development plan (s). You will lead the development of the clinical protocol and participate ... (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s) Responsible for scientific leadership and execution… 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)
- … plans and ensure alignment with the overall brand/OneMedical strategy. Review publications, help create medical backgrounders, FAQ and standard responses, and ... the overall company strategy and cross functional alignment.Development and execution of MA plans : ensure that strategy is reflected in medical plans and that… more
- Ace Hardware Home Services (Alpharetta, GA)
- …building codes or specifications to determine work details and procedure. Studies building plans and inspects structures to assess material and equipment ... needs, establish sequence of pipe installations, and plan installation around obstructions. Measure, cut, thread, bend, ream, and install pipe and pipe fittings.… 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
- Insmed Incorporated (NJ)
- …a "Quality Mindset" is in place across the organization by focusing on detailed plans to monitor the conduct of our studies, the management of our vendors and ... manage a process for Inspection Readiness.Contributes to the development and review of regional/global policies and procedures. Ensure compliance with all… 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. (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
- 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
- Genmab (NJ)
- …share learningsRepresents Genmab during Key Opinion Leaders meetings Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans , ... At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody… 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
