- Merck & Co. (Rahway, NJ)
- … management decisions and strategies.Utilize statistical methods to interpret risk data , providing clear and actionable recommendations rooted in empirical ... Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead, is a crucial...device systems.Strong analytical and statistical skills with experience in data interpretation and risk assessment tools.Excellent communication,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four functional areas: ... a critical part in designing and driving the core risk management operations of the E&C team,...CECO reporting to internal and external stakeholders Oversees the management and enhancement of the technology and data… more
- Genmab (Plainsboro, NJ)
- …and ongoing oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and protection policies.Works ... to fulfilling our purpose.The Role.The Director, Privacy Technologist & Third-Party Privacy Risk reporting into the Head of Global Data Privacy Program,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data ... study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and… more
- Merck & Co. (Rahway, NJ)
- …payroll applications and collaborate with the Middleware team (Informatica, TIBCO) for data mapping.Manage and design IT risk assessments, including identifying, ... Compensation and Benefits and other related solutions.Lead end-to-end project management for HR Compensation and Benefits initiatives, including planning,… more
- Aequor (South San Francisco, CA)
- …ultimate goal of driving data -driven decision-making throughout the study lifecycle. The Risk Based Quality Management (RBQM) Data Analyst sits in the ... science-related consultation to the study teams. We leverage cutting-edge data science and operation data management...teams to conduct data surveillance and issue management by defining consistent risk control strategies… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …The Position This position is responsible for the ownership of the Engineering Data Management System (EDMS) while collaborating with the Engineering team to ... commissioning documents, validations, engineering test plans, SOPs, etc. The engineering data management area is responsible for establishing engineering … more
- Novo Nordisk Inc. (Los Angeles, CA)
- … identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager, Clinical Data Repository Administration is a member of the Biostatistics and Data Management Data Operations team and serves both as a subject ... and oversight of the group. This position reports to the Associate Director Data Management Operations. Business administration activities within the CDR system… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Merck & Co. (Rahway, NJ)
- …Matter Expert,Conduct of contractor "deep dive" quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality ... and 10 years overall within biopharmaceuticals.Planning and facilitating high risk and highly complex Quality-related process reviews and/or investigations under… more
- Genmab (Plainsboro, NJ)
- …approving the CV of PL/PMRisk ManagementIdentify study risks with the CTT and oversee risk management activitiesMaintain and oversee the CTT issue log and ensure ... the CTM role too.ResponsibilitiesLead the Clinical Trial Team (CTT) and Trial Management (TM) teamDefine and align CTT goals collaboratively with the teamReview and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and...approaches to data review in conjunction with Data Management and Clinical Science, audit trail… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …CPP/CQAs are defined and understood by engineering and incorporated into design and control functions. Risk Management - assures risk management decisions ... health of the manufacturing processes. This starts with proper risk analysis in manufacturing design, then goes into addressing...and other regulatory agency audits. Serve as an Internal Auditor. Data Management - perform statistical data … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …teams prepare for governance interactions. Independently manage interactions with clinical leads, data management , safety, regulatory, and QA team members, both ... implementation of study objectives. Implement and use efficient project management tools, eg, Communication Plan and Risk ...or internally) to ensure robust oversight for study level data review, including trend evaluation and full risk… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Strong understanding of the intelligence cycle, especially collection, assessment, and management of primary data Work independently with ability to guide ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... all dosage forms (liquid, lyo, drug-device combinations)Review and approval of data and technical documentsAbility to recruit, select, develop, and mentor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at ... Phase 3/4 program.This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this… more
- Merck & Co. (Rahway, NJ)
- …and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and requirements. ... of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development,… more
