- The Indigo at Elmhurst (Elmhurst, IL)
- …operations, including staff leadership, budgeting, occupancy goals, resident satisfaction, and regulatory compliance . The Director ensures resources are ... Executive Director We are seeking a strong and compassionate...primary on-call leader for emergencies and operational needs. Uphold compliance with policies, state regulations, and HIPAA requirements. What… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...to all appropriate departments in Formation Bio to assure compliance with applicable regulations. Remains knowledgeable about current regulations… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role The Associate Director , External Data Quality Management, is a strategic leadership role supporting high-quality ... and integrity of external data across the clinical programs.The Associate Director will guide cross‑functional teams, oversee external data quality and vendor… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (North Wales, PA)
- …teams, driving the strategy from ideation to value realization.- The Senior Director will: Drives Alignment and Strategic Planning Inspires teams toward shared ... management and functional operations to internal teams and external partners Ensures Compliance Oversees compliance of the teams executing processes according to… more
- Insmed Incorporated (NJ)
- …requires a blend of technical expertise and business acumen to ensure regulatory compliance , system integrity, and alignment with business objectives across ... as the IT System Owner for the Learning Management System and compliance IT systems, which includes supporting GxP-regulated applications, while also functioning as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. ... as well as with all applicable regulatory requirements.Support GxP regulatory inspections as required.Support the local Compliance and auditing teams… more
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there’s only one choice. Senior Director , Digital Governance & LMR Lead The Senior Director , Digital Governance & ... via enhanced strategic USMA Governance, proactively oversees the local Legal-Medical- Regulatory approval procedures and ensures maximal effectiveness while mitigating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the integrity, transparency, and governance of global forecasts, ensuring compliance with internal policies and external regulatory requirements.Lead audit ... research areas centered around rare diseases and immune disorders. Job Summary Director , Global Oncology Forecasting will be responsible for leading and owning… more
- Insmed Incorporated (NJ)
- …company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management ... of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Senior Director of Quality Operations as part of the Quality team based in Raritan, ... NJ.Role OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities...United States and ensure the sites operate in full compliance with established cGMP requirements. This individual will be… more
- Eisai, Inc (Nutley, NJ)
- …performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance frameworks, and compliance with ... with a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and executes outsourcing… more
- Merck & Co. (Rahway, NJ)
- …biologics, and vaccines. Be part of a dedicated team that thrives on compliance and robustness, driving excellence in logistics technology and making a meaningful ... critical flaws.Experience and knowledge of the pharmaceutical environment including regulatory requirements.Familiarity with application of Lean Six Sigma principles,… more
- Insmed Incorporated (NJ)
- …review and approval process. You will ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality ... the future of science, we're in. Are you?About the Role:The Associate Director , Medical Review Committee (MRC) Operations is responsible for managing the operational… more
- Eisai, Inc (Philadelphia, PA)
- …and compliance with Eisai policies and procedures and applicable regulatory authority directives and regulations. Analyze competitor labeling and ensure Eisai ... your profile, we want to hear from you. The Director , Global Labeling is responsible for the leadership and...leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage… more
- Insmed Incorporated (NJ)
- …responsible for creating and implementing programs that ensure workplace safety, regulatory compliance , and environmental protection for all Insmed locations.Key ... consultants for instruction in subjects relating to health and safety and regulatory compliance (laws, regulations, requirements). Ensuring the proper execution… more
- Eisai, Inc (NJ)
- …strategies that deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages ... your profile, we want to hear from you. The Director of Clinical Outsourcing is responsible for leading the...and partner with Vendor Risk Assessment teams to ensure compliance with regulatory requirements and alignment with… more
- Merck & Co. (North Wales, PA)
- Job DescriptionAssociate Director US Marketing, HCP Strategy - OphthalmologyOur company is dedicated to delivering innovations that extend and improve the lives of ... (nAMD), and retinal vein occlusion (RVO)).-We are currently recruiting for an Associate Director US Marketing, HCP Strategy - Ophthalmology. This is an exciting time… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment, ... Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ultimately negotiated with assigned accounts. Relationships Reports to the Executive Director / Director on the Strategic Pricing and Contracting team. Works ... Rare Disease), as well as with internal stakeholders (Government Contracts & Compliance , Rebate Operations and Insights, Market Access Strategy, Legal, and others).… more
