- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on ... Expert - Signal Evaluation: Assists manager in assessing new signals. Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, 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
- Merck & Co. (Rahway, NJ)
- …responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes defining and optimizing ... and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Lead position will report to the Director , ... Responsibilities include the following:The process/facility lead role at the Associate Director level will serve as a technical mentor and operations team… 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)
- …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.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate ... Director .This position will have overall responsibility for oversight and...biologics manufacturing site.Lead numerous projects including process improvement and safety initiatives.Coordinate / oversee capital projects.Develop and monitor annual… more
- Merck & Co. (North Wales, PA)
- … safety experience or related areas such as Clinical Risk Management, Clinical or RegulatoryPreferred:Strong knowledge base of pharmacovigilance regulations and ... the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to drugs, vaccines, biologics, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …nurses) at the site level to ensure that patient safety with respect to the safety risk assigned remains top of mind in the context of patient management in ... of the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving ... compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including study design,… more
- Merck & Co. (North Wales, PA)
- …and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the planning and ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including: study… more
- Merck & Co. (Rahway, NJ)
- …Critically, the Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have extensive drug product ... skills.The role is based in New Jersey and reports to the Executive Director of FLEx Non-Sterile Operations in Pharmaceutical Operations & Clinical Supply.- Primary… 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.Develop a strong, positive strategic business partnership with the global R&D business functions of Daiichi Sankyo. As a trusted partner,… 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. Develop a strong, positive strategic business partnership with the global R&D business and Global IT functions of Daiichi Sankyo. As a… more
- Merck & Co. (Boston, MA)
- …leader to join the Boston Discovery Chemistry Leadership Team as a Director (M3). The successful candidate will be responsible for multidisciplinary portfolio ... support the sustained delivery of a multi-modality portfolio. In addition, the Director will participate in department- and network-wide activities such as resource… 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
- 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
- Merck & Co. (Durham, NC)
- …report overall status and health of the partnership; identify areas of risk or opportunity to the respective business areasProactively identify and resolve ... capabilities in managing alliancesSpecific to the MBLC:Develop and deploy a lab safety program and achieve safety metricsOversee facility management including… more
- Merck & Co. (Durham, NC)
- …supporting the Maintenance & Engineering as well as Environmental, Health, and Safety product lines in close collaboration with Manufacturing Operating Units, Global ... Safety and Environment (GSE), and Global Engineering Solution (GES)...that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent… more
- Merck & Co. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study… more
