- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Design Control and Risk Management Data Manager, you are a key member of the Device Development Team. Your will main responsibility is to ... -Key responsibilities include the following: Partner with the Design Control and Risk Management leads to determine the data relationships and mapping.Lead… more
- Merck & Co. (Philadelphia, PA)
- …Labor and Human Rights Audit Program as neededEnsures appropriate escalation of risk management gaps, issues, and concerns to managementManages activities ... Matter Expert (SME), leading system administration, answering user questions, and management of external risk data providers. Responsibilities also extend… more
- Novo Nordisk Inc. (WA)
- …integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North America Clinical ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and… more
- Merck & Co. (North Wales, PA)
- …DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of our ... full potential. The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient influence and mastery… more
- Novo Nordisk Inc. (Irvine, CA)
- …integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North America Clinical ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and… 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 ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… 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 ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (North Wales, PA)
- …for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management , and other company ... communicate results of clinical trials to the project team, company Management , regulatory agencies, or individual investigators.Provides responses to queries… more
- Merck & Co. (North Wales, PA)
- …the positionServe as a statistical representative and core member in multiple Risk Management Safety TeamsLead, coordinate, and provide biostatistical support ... (CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and… more
- Merck & Co. (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... reporting and interpretation of dataMaintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
- Merck & Co. (North Wales, PA)
- …projects under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other of our ... effectively communicate results of clinical trials to the project team, management , regulatory agencies, or individual investigators.Provides responses to… more
- Merck & Co. (North Wales, PA)
- …for the position:Serve as a statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related ... (CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and… more
- Merck & Co. (Durham, NC)
- …for maintaining a safe work environment Meeting and driving projects and change management ensuring technical support needs are met Schedule adherence and right the ... projects and run the business activities - Decision making - Stakeholder management - Issue identification and resolution - Understanding of capacity and demand,… more
- Merck & Co. (North Wales, PA)
- …leadership and support for early-stage clinical oncology programs.Interact with Clinical, Regulatory , Statistical Programming, Data Management , and other company ... communicate clinical trial results to the project. team, company Management , regulatory agencies, or individual investigators.Independently identifies and… more
- Merck & Co. (Rahway, NJ)
- …to develop a breadth of experience including finance, accounting, analytics, risk management , and special project opportunities.MCAAS Innovation FLDP ... strategy; this includes a deeper knowledge of internal controls, business compliance, and risk management . Individuals will be based in the global headquarters… more
- Merck & Co. (Upper Gwynedd, PA)
- …on asset cross-functional meetings: Franchise Teams, Clinical, Outcomes Research, Risk Management , and Commercial Asset Development Subteams, Publication ... patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset management issues.This is a… more
- Merck & Co. (Rahway, NJ)
- …geo-political trends, and proactively directing policy development activities to mitigate risk and leverage opportunities in support of our company's business ... and maintain digital tools to support best-in-class strategic planning and performance management across the policy function and work with the AVP, Strategic… more
- Aequor (Seattle, WA)
- …documents, and corrective and preventive action (CAPA) plans in accordance with regulatory standards and company policies. 2. Deviation Management : Collaborate ... with regulatory guidelines (eg, CLIA, CAP, ISO) and quality management systems. Excellent written and verbal communication skills; ability to convey complex… more
- Merck & Co. (Rahway, NJ)
- …packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Have deep fundamental knowledge around large molecule ... drug product development and have management responsibilities for a small group of scientists during...to ensure completion of key milestones and laboratory / regulatory documentation. Active strategic and technical leadership on program… more
- Merck & Co. (Rahway, NJ)
- …to develop a breadth of experience including finance, accounting, analytics, risk management , and special project opportunities.Corporate Audit and Assurance ... strategy; this includes a deeper knowledge of internal controls, business compliance, and risk management . Individuals will be based in the global headquarters… more
