- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Independent Medical Education (IME) Assist in developing medical education priorities and IME plan in collaboration with IME lead Review and assist with ... within a therapeutic area, including developing the medical product and evidence generation plans based on insights from the marketplace. This role may also lead the… 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
- Merck & Co. (Rahway, NJ)
- …States Benefit plans for Union and Non-Union employees. Responsibilities Benefit Plan Lead Lead ongoing administration and special projects for United States and ... operations initiatives related to our Company's United States Pension plan & Puerto Rico Retirement and Health & Welfare...& Puerto Rico Retirement and Health & Welfare benefit plans with a variety of stakeholders. This role requires… 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 (Boston, MA)
- …Executives to work with downstream regional payer accounts of the national payers. Review and analyze applicable data to make informed decisions on regional payer ... stakeholders. Work with various key internal stakeholders to align national account business plans with brand plans and effectively implement those plans … more
- Professional Engineering Consultant (Wichita, KS)
- …accordance with qualify assurance policies, standards and project specifications Prepare and review engineering plans and drawings Assist in the preparation of ... Strong attention to detail and accuracy in preparing engineering plans , reports, and documentation Familiarity with local regulations, permitting processes,… more
- Novo Nordisk Inc. (Buffalo, NY)
- …others within the influence map) Researches, understands and tailors account plans based on stakeholders and accounts business practices Utilizes understanding of ... and patient needs to develop and execute territory business plans Develops and implements plans to gain...exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications Bachelor's or equivalent… 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
- Cipla (Fall River, MA)
- …offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), ... with TrackWise applications for handling Deviation and CAPA. Prepare and review the investigation related to deviation, OOS, market complaints and microbiological… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …annual performance cycle. Develops and maintains medical (territory and account) plans in coordination with his/er Field Director. Relationships Position reports to ... value and develop collaborative relationships Establishes the medical account strategy/ plan through the identification and cultivation of key relationships and… more
- Eisai, Inc (Nutley, NJ)
- …investigations and implementing any resulting mitigation and/or remediation plans , supporting cross-functional teams on information governance, partnering with ... in compliance with state, federal and global privacy laws. Draft, review , update and negotiate privacy-related agreements, consents, disclosures, and notices.… more
- Cipla (Fall River, MA)
- …packing material and finished goods by aligning with the production plan and coordinating with purchase, production, etc. to support manufacturing effectively ... Responsibilities: Maintain the availability of required materials as per production plan to ensure uninterrupted production and help achieve manufacturing OTIF… 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
- Aptyx (Charlotte, NC)
- …in the quotation process for projects Develop feasibility and reliability testing plans for catheter systems, including the development and validation of accurate ... for devices Assess feasibility of processes and support manufacturing with validation plans and time studies Support product manufacturing until the project is fully… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Requires experience and collaboration with the Medical, Regulatory and Legal review process. Essential Functions Develops a deep understanding of disease states, ... decisions Leads the creation and execution of innovative strategic and tactical plans , grounded in customer insights, to differentiate the brands and drive… more
- Eisai, Inc (Baltimore, MD)
- …difference. If this is your profile, we want to hear from you. Designs, plans and executes biostatistical components of plans for research and development ... specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in… more
