- Legend Biotech USA, Inc. (Raritan, NJ)
- … assessments; and ensuring accountability of team members for deliverables. Additionally, the Risk Assessment lead will communicate across functional and ... as problems and solutions, and implement and manage change when necessary to meet risk assessment outputs. Lead issue oriented Risk Assessment … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to risk management. Keeps management aware of any gaps in risk management planning, creation, and execution- Lead /Manage RMP initiatives. Lead ... Job Summary:This position will be a member of the Risk Management Center of Excellence office who will help...following the status of submissions). 5) Guides in creating assessment reports. 6) Guides and supports with the alignment… more
- Eisai, Inc (Nutley, NJ)
- …security and data privacy standards. Your responsibilities span security operations, risk assessment , investigations, and compliance issue resolution for the ... compliance policies.Assess inherent and residual IT compliance risks using a risk assessment framework.Oversee documentation, implementation, and testing of IT… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that audit targets for tactical and strategic GVP audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within ... internal QA stakeholders such as GMP QA, specifically for GDP requirements, risk -based assessment for Distributors, co-partners, and affiliates. Liaise with… more
- Merck & Co. (Rahway, NJ)
- …CMC sections of regulatory submissions and associated source technical reports and risk assessment documents. The ideal candidate should bring expertise in ... primary role of the successful candidate will be to lead the design, method development, optimization and transfer of...variety of immunological and cell methods and technology for assessment of biological potency with an emphasis on subject… more
- Eisai, Inc (Nutley, NJ)
- …security controls and processes to protect the organization's infrastructure assets.7. Risk assessment and mitigation: Collaborate with the Global Security ... Security Engineer is responsible for building out the organizational capabilities to lead and manage Eisai's security engineering activities related to Identity &… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …based on the MOA and initial toxicological profile. Provide a first, preliminary benefit/ risk assessment and make available to senior leadership at DP0. Surface ... the person filling this role will pioneer and eventually lead a new group within CSPV. He/she will spearhead...Assist teams in maintaining oversight of changes to the benefit/ risk balance. Provide expert input on surveillance, assessment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspective- May provide clinical input into the eCRF ... data review per Integrated Data Review Plan- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety… more
- Merck & Co. (Rahway, NJ)
- …filings.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.Maintaining an ... In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include...that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAPA implementation. Indirectly oversee Investigations Managers, providing guidance and support. Risk Assessment and Prioritization: Conduct risk assessments ... initiatives to enhance investigation quality, timeliness, and productivity.Key Responsibilities Co- Lead Deviation Investigations: Collaborate closely with the Quality Associate… more
- Merck & Co. (Rahway, NJ)
- …attaining desired results. Reviews and defends stage-gate deliverables for programs, including risk assessment and mitigation plans, and engages in corporate ... skills.Job Specific Competencies & Skills:Demonstrated ability to understand, manage and lead in a multi-cultural atmosphere, with an employee base that is… more
- Catalent (St. Petersburg, FL)
- …and conduct Pre-Audit Preparation activities with an understanding of requesting sites risk assessment to ensure alignment to Global Standards Ensure generation ... the quality teams globally during the management of supplier quality issues Lead and support Supplier issues / investigations affecting Catalent sites 50-60% travel… more
- Merck & Co. (North Wales, PA)
- …research including design and implementation of retrospective database studies, assessment of patient reported outcomes, epidemiological studies and economic ... Care. Specific roles include but are not limited to: Lead one or more Value Teams (VT) and provide...that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent… more
- Merck & Co. (Rahway, NJ)
- …undertaking a project, program or portfolio, including the benefit, cost and risk of alternative options, and rationale for the preferred solution.Assist with the ... cost data as it relates to the calculation and reconciliation of Intercompany Profit. Lead the planning, designing, and assist the business on the coordination of… more
- Merck & Co. (North Wales, PA)
- …other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.Implements ... (CMC) as well as other functional areas (eg, Clinical Research, Safety Assessment ).Supports maintenance (eg, quality compliance and life cycle management) of VID… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance...validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing subject… more
- Merck & Co. (Boston, MA)
- …own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development). Lead key technical reviews for Immunology assets.Conduct DRC reviews. ... well as other disciplines.Establish novel endpoints for early clinical assessment leveraging experimental medicine paradigms.Enable clinical leads and TMed co-chairs… more
- Merck & Co. (Rahway, NJ)
- …own Cardiovascular & Respiratory strategy with other TA Heads (Discovery/Late-Stage) Lead key technical reviews for Cardiovascular & Respiratory assets Conduct DRC ... well as other disciplines Establish novel endpoints for early clinical assessment leveraging experimental medicine paradigms Enable clinical leads and TMed co-chairs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and preventive actions, as necessary. Supports internal/external audits. Supports Quality risk assessment teams. Review/approve documents as a Quality on ... Experience directly supervising employees is preferred. Ability to work with and lead others in a team environment. Demonstrated ability to develop and set… more
- Marion County (Salem, OR)
- …you to join our expanding Adult Behavioral Health Program to support a high- risk and underserved population. In this position, you would provide mental health ... and have creative problem-solving skills. This position may act as a lead clinician providing clinical consultation and assistance to interns and other staff… more
