- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety , will be a product safety lead or ... for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director or Executive Director Safety Surveillance, US East Coast ... Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management...reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Executive Director - Safety Surveillance, US East Coast Development Hub. Key ... ECs, DMCs, and Academia. L ine management responsibility of Director /Associate Director Global Safety Lead,...Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Executive Director of Global Safety US East Coast Development Hub. Key internal ... Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management...reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work in a growing ... Department that manages multiple early to late-stage clinical programs. The Associate Director role will be responsible for all aspects of clinical trial management… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... to maximize your potential with us? The Position As the Associate Director of Strategic Market Insights, the functional responsibilities include leading analyses of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... agreements including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works (SOWs). The AD will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision ... elements to achieve a Quality by Design (QbD) and Risk -Based Quality Management (RBQM) approach to clinical trial conduct....to RBQM CSM to improve quality and ensure patient safety and data quality and integrity.Establish, measure, analyze and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to a Technology Director in Global Engineering Solutions (GES), the Associate Director will be part of a high performing team, ... of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case development through… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the development of clinical sections of study-level documents (eg, protocol, amendments)Reviews safety data to mitigate risk to trial participants for the ... areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management, Regulatory 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. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the ... team of individual contri butor production direct reports including safety , quality, and daily operations ; - E nsure...plan; receives gui dance and oversight from Operations Associate Director and Director ; - - Interprets… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... and indirect compliance, handling state tax audits and notices, evaluating state tax risk , and ensuring realization of state credits and incentives for all Novo… more
- Merck & Co. (Durham, NC)
- …high-quality vaccines to the patients around the world. With our core principle of Safety First and Quality Always EMSS strives to have the safest and most compliant ... operation around the network.EMSS has an Associate Director opening for the Bulk Facility (GBF) maintenance team. The selected candidate will manage the engineering,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding ... working knowledge of medical terminology capture and reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements.… more
- Fidelity Investments (Boston, MA)
- …risks to assist management in improving their controls and processes.The PositionThe Director , Asset Management Risk , Cryptocurrencies and Digital Assets will ... Job Description:The TeamAsset Management Risk provides direction to management and business units...Onsite. At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Manager II is responsible for being in compliance with all safety policies, cGMPs, and SOPs.Job Responsibilities:Manage large-scale, complex projects or multiple ... comprehensive project plans, manage schedules, and monitor resource allocation.Conduct risk assessments, develop mitigation strategies, and proactively address issues… more
