- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire ... IT business stakeholders on business continuity, governance, and audits.Manage global IT Risk Management Procedure and third-party risk assessments.Establish… more
- Merck & Co. (Rahway, NJ)
- …Principal Responsibilities- Lead /contribute to device development, design controls and risk management strategy for the assigned projects. Lead ... apply regulatory / compliance requirements relative to design controls and risk management activities. Lead the preparation of materials for program… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description As a Design Control and Risk Management Data Manager, you are a key member of the Device Development Team. Your will main ... include the following: Partner with the Design Control and Risk Management leads to determine the data...Management leads to determine the data relationships and mapping. Lead data review meetings with content owners and Quality.Create… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), ... programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... Lead is established, take main responsibility for CMC lead . Provide operational coordination and management to...for CMC lead . Provide operational coordination and management to drive strategies and activities for early and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... timelines and resource requirements for CSV projects. Work within a risk -based framework (Computer Software Assurance (CSA)) that is compliant with global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and implement modifications to risk assessment plans.Key Responsibilities Follow QRM (Quality Risk Management ) process per ICH Q9, identify the risk , ... and ensuring accountability of team members for deliverables. Additionally, the Risk Assessment lead will communicate across functional and leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor selection process in collaboration with the study team and outsourcing procurement management . Lead the creation of the CRO scope of work in collaboration ... with Outsourcing Procurement Management . Lead trial feasibility and site identification activities...and relevant governance bodies.Triage, resolve or escalate study issues / risk mitigations to the Operations Program Lead … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for ... local authorities as necessary to address compliance relevant matters and lead any remediation efforts. ResponsibilitiesLeads nonclinical QA function to implement a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1-3 ... questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)May participate in Site Initiation Visit (SIV)… more
- Merck & Co. (Rahway, NJ)
- …Units (OpUs) as it relates to in-line product management , supplier management , risk management and savings identification.Works closely with DMLT ... while remaining a financial steward.Scope:-Responsible for all in-line product execution, risk management and escalation.-Emphasis on matrix management … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 - ... eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)- May participate in Site Initiation Visit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 - ... questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)May participate in Site Initiation Visit (SIV)… more
- Eisai, Inc (Nutley, NJ)
- …occurrences. This role will be required to provide input into vulnerability management , risk management , security architect, security operations center ... Demonstrated expertise in incident response, threat intelligence, security controls, and risk management .- Solid understanding of protocols (ie., SAML, SMB,… more
- Merck & Co. (Rahway, NJ)
- …communicate the importance & urgency for early LDL-C treatment for Cardiovascular Risk Management .Embed patient insights within the commercial perspective across ... communicate the importance & urgency for early LDL-C treatment for Cardiovascular Risk Management .Embed patient insights within the commercial perspective across… more
- Merck & Co. (Rahway, NJ)
- …Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... Sterile Product Development (SPD) team. The successful candidate will be expected to lead the team focused on the design of new formulations and development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management .Responsibilities- Acts as a brand attorney and lead legal advisor ... Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and...and for review, approval, and use by Legal Affairs management . Independently negotiates contracts and other issues with third… 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 ... Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of ... end-to-end: understanding predisposing non-clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services, Project Management and Operational Management . Develop a strong, positive strategic business partnership with the… more
