- Merck & Co. (Rahway, NJ)
- …checks are performed and discrepancies resolvedOversee IP docketing system to ensure data integrity , accuracy, and compliance with rules and departmental ... Space Planning, Strategic Planning, Vendor Management, Working IndependentlyPreferred Skills: Data Integrity , Problem SolvingCurrent Employees apply HERE Current… more
- Merck & Co. (Rahway, NJ)
- …others.-Knowledgeable of cGMP's, financial principles, QA policies, safety guidelines, data integrity guidelines, engineering standards, and regulatory issues.- ... Sciences colleagues.-Recommends and executes programs of value to the Company which lead to availability of Clinical Supplies and Development Batches to meet… more
- Insmed Incorporated (NJ)
- …and integrity of clinical studies.Perform medical monitoring, coding, and data cleaning, and prepare Investigator Alert letters and SAE reports in collaboration ... Gene Therapy, the Executive Director will have responsibility to lead clinical programs across different diseases and supervise the...with Clinical Operations.Ensure the medical integrity of clinical study reports and data … more
- ValSource, Inc. (Rahway, NJ)
- …methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity . Project Management experience in managing scope, cost, schedule, ... and ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn- Site Project Management: Interface with clients, lead teams of… more
- Merck & Co. (Rahway, NJ)
- …part of the US Controller's Organization, this role helps ensure financial integrity by providing accounting and divisional business support for US entities within ... ensure activities operate in a well-controlled financial environment by maintaining the integrity of the general ledger including compliance in accordance with GAAP,… more
- Insmed Incorporated (NJ)
- …adherence, administration and oversight of study budgets, monitoring oversight of site -level activities related to ongoing and planned trials, management of ... by vendors and assigned program staff.Manages global monitoring oversight of site -level activities related to ongoing and planned trialsDevelops and manages detailed… more
- Insmed Incorporated (NJ)
- …FDA/EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, Data Integrity .Knowledge of the FDA Computer Software Assurance (CSA) fundamental ... of the CSV function including managing CSV system folders in the CSV SharePoint site , managing CSV documents in Veeva, routing documents for review and approval in… more
- Wyndham Hotels & Resorts (Parsippany, NJ)
- …to live our unique Count on Me culture, set by our core values of integrity , accountability, inclusive, caring and fun. At Wyndham, we provide all team members the ... delivery aligns with architectural vision and hospitality best practices, ensuring data governance, privacy compliance, performance optimization, and guide the use… more
- Winland Foods (Fair Lawn, NJ)
- …(HRIS), Workday, for data entry, reporting, and regular audits to ensure data integrity + Generate reports to identify workforce trends and measure program ... This front-facing role supports all levels of team members at the site , while actively participating in broader company initiatives. The successful candidate plays a… more
- Organon & Co. (Jersey City, NJ)
- …the drug product life cycle, including interpretation of relevant dissolution data . The scope includes small molecules and biologics/biosimilars, simple and complex ... an important role in the preparation of biowaiver requests for manufacturing site changes or active pharmaceutical ingredient or excipient supply source changes… more
