- Merck & Co. (Rahway, NJ)
- …leading and implementing medical device and combination product design controls and risk management activities for both new products and inline products from ... at least one medical device development or design controls and risk management areaKnowledge of US and global medical device and healthcare regulations,… more
- Eisai, Inc (Nutley, NJ)
- …IT business stakeholders on business continuity, governance, and audits.Manage global IT Risk Management Procedure and third-party risk assessments.Establish ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides... Risk and Compliance initiatives and support professional growth. Risk Management : Develop and manage global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Head of Risk Management US provides leadership to ensure the optimal design and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...alignment of all risk management functions in support of the… 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...Technology, Engineering, or Math (STEM) field0-2 years in the medical device or pharmaceutical industry. Required experience and skills:… 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 , ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Risk Assessment Specialist as part of the Technical Operations team based in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... hours per week. Responsibilities: This internship will support multiple projects in IT Risk & Security Governance. Partnering with team members, the intern will gain… 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 ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management , Medical Affairs, Regulatory Affairs and other NNI skill ... including NNI Evidence Generation Plans and Product Development Plans Clinical study management : Provide regional medical & scientific input on trial outlines,… more
- Aequor (Thousand Oaks, CA)
- …for leading cross-functional teams in new raw material onboardings, life-cycle management projects, and continuous improvement initiatives. This will require working ... of life-changing medicines. Activities may include analyzing opportunities, project management (scoping, chartering, and strategy), process improvement, and change … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical ... with the PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Eisai, Inc (Nutley, NJ)
- …occurrences. This role will be required to provide input into vulnerability management , risk management , security architect, security operations center ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...expertise in incident response, threat intelligence, security controls, and risk management .- Solid understanding of protocols (ie.,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and risk assessments to inform decision-making and prioritize initiatives Risk Management : Proactively identify and mitigate risks associated with product ... / medical (CMR) teams to ensure alignment of lifecycle management strategies with broader organizational goals and objectives. Facilitate communication and… 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 ... robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... disorders. Job Summary: Serves as a primary source of medical accountability and oversight for one or more clinical...and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Summary / Objective Serves as a primary source of medical accountability and oversight for one or more clinical...and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and interpretation of Oncology clinical trials. Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current clinical practice ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …but not limited to protocol amendments, Dear HCP letters and key medical education initiatives.Develops prospective contingency plans for management of assigned ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
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