- Merck & Co. (Rahway, NJ)
- … management decisions and strategies.Utilize statistical methods to interpret risk data , providing clear and actionable recommendations rooted in empirical ... Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead, is a crucial...device systems.Strong analytical and statistical skills with experience in data interpretation and risk assessment tools.Excellent communication,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four functional areas: ... a critical part in designing and driving the core risk management operations of the E&C team,...CECO reporting to internal and external stakeholders Oversees the management and enhancement of the technology and data… more
- Genmab (Plainsboro, NJ)
- …and ongoing oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and protection policies.Works ... Role.The Director , Privacy Technologist & Third-Party Privacy Risk reporting into the Head of Global Data...team to establish third-party oversight strategy and support ongoing management of third-party data privacy and protection… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in ... Data Management Operations for the Data Validation and... protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …teams prepare for governance interactions. Independently manage interactions with clinical leads, data management , safety, regulatory, and QA team members, both ... implementation of study objectives. Implement and use efficient project management tools, eg, Communication Plan and Risk ...or internally) to ensure robust oversight for study level data review, including trend evaluation and full risk… more
- Merck & Co. (Rahway, NJ)
- …payroll applications and collaborate with the Middleware team (Informatica, TIBCO) for data mapping.Manage and design IT risk assessments, including identifying, ... Compensation and Benefits and other related solutions.Lead end-to-end project management for HR Compensation and Benefits initiatives, including planning,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Strong understanding of the intelligence cycle, especially collection, assessment, and management of primary data Work independently with ability to guide ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… 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 ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, ... Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, ... Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and...approaches to data review in conjunction with Data Management and Clinical Science, audit trail… more
- Merck & Co. (Rahway, NJ)
- …and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and requirements. ... of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, ... Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as… more
- Merck & Co. (Rahway, NJ)
- …Matter Expert,Conduct of contractor "deep dive" quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality ... and 10 years overall within biopharmaceuticals.Planning and facilitating high risk and highly complex Quality-related process reviews and/or investigations under… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Genmab (Plainsboro, NJ)
- …their skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management . ... in handling integration management , process and continuous improvement management , digital or data technology, operations, supply chain, manufacturing,… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... submission strategy for the compound. You must have strong project management capabilities and will be responsible for planning, coordinating, and executing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, ... development of clinical sections of study-level documents (eg, protocol, amendments)Reviews safety data to mitigate risk to trial participants for the assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing… more
