- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and application and other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical ... globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log)… 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)
- …of Company and/or departmental expectations and goals as identified by senior management .ResponsibilitiesActs as a brand attorney and lead legal advisor for ... 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)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Merck & Co. (Rahway, NJ)
- …Material(s):Required Skills:Measurement Analysis, Portfolio, Programme, and Project Support, Program Management , Risk Management , Stakeholder Relationship ... Job DescriptionWe are seeking a dynamic and experienced IT Infrastructure Lead to join our Capital Projects IT Infrastructure team.- Our team is dedicated to the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …capability to ensure processes are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the ... Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team...manufacturing operations.Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processesAbility to work… more
- Merck & Co. (Rahway, NJ)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving...and Hub data and experience with patient journey and risk stratification is a plusTranslate use cases into implementation… more
- Formation Bio (New York, NY)
- …health authority audits.Responsibilities Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory ... ensure the consistent production of safe, effective, and high-quality pharmaceutical products. Lead internal and external audits to assess compliance with… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... and local site procedures for safety, quality, and regulatory compliance - Understand the big picture, and how activities link...to our Company strategy and business goals- Utilize device risk management tools to build device or… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Merck & Co. (Rahway, NJ)
- …and manage company's safety standards and technical guidelines to ensure compliance and reduction in workplace safety risks. Lead global continuous ... Programs CoE.- This individual will be responsible for the management of a portfolio of corporate safety programs that...portfolio of corporate safety programs that may include High Risk Work, Fire & Life Safety and other similar… more
- Merck & Co. (Rahway, NJ)
- …customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as… more
- Merck & Co. (Rahway, NJ)
- …talent Development.-The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- …criteria, post program satisfaction ratings, behavioral changes , and knowledge retention - Lead design updates and own lifecycle management of internal learning ... will report to the Animal Health Learning & Development (L&D), Program & Communications Lead . Th is individual will be responsible for supporting our G lobal ,… more
- Merck & Co. (Rahway, NJ)
- …efficiency and yield improvements. Additionally, the candidate will utilize Quality Risk Management methodologies and statistical design of experiment tools ... communication and collaboration skills.Good organizational, interpersonal, writing, and time management skills. Lead and operate within a cross-functional process… more
- Merck & Co. (Rahway, NJ)
- …timely and accurate information and status updates to project sponsors and management .Champion compliance and safety; promote a culture of diversity, inclusion, ... Coordinate project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/technical mentor for junior staff.- Provide… more
- Merck & Co. (Rahway, NJ)
- …for proactive resourcing planning, risk assessment strategies, and budget management as necessary.The Director, Nuclear Magnetic Resonance Lead , is expected ... opportunity for a Director of Nuclear Magnetic Resonance (NMR).- The NMR Lead provides strategic and technical leadership for NMR capabilities across our… more
- Formation Bio (New York, NY)
- …change management , and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs, performs critical ... of QA. Assure the execution of QA Audit Plans, Lead internal and external audits to assess compliance...corrective and preventive actions (CAPA effectively. Proficiency in quality management tools and methodologies (eg, risk assessment,… more
