- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data ... for direct reports, and mentors DM Operations Data Validation and Reporting staff.Directs programming representation in audits and regulatory inspections… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Director , EHS (Environmental, Health, and Safety) isa senior-level role responsible for creating ... and implementing programs that ensure workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key duties include risk… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads quality assurance and process improvement ... training, and data-driven optimization aligned with Insmed's strategic goals.The Associate Director , Patient Services Quality & Process is responsible for overseeing… more
- Insmed Incorporated (NJ)
- …requests Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, ... future of science, we're in. Are you?About the Role:The Associate Director , Programming provides technical leadership and ensures adequate programming support for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports for medical content, evaluation of expectedness/listedness and assessment of regulatory status for expedited reporting Design, implement, and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers… more
- Insmed Incorporated (NJ)
- …operational aspects of clinical study planning, implementation, data delivery and reporting . Represents Clinical Operations in a range of cross-functional groups, ... 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations. Ensures consistent and successful execution of operational… more
- Insmed Incorporated (NJ)
- … regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk Management plays a critical leadership role in ... safeguarding that mission. Reporting directly to the Chief Information Officer, this individual is responsible for defining and executing Insmed's enterprise… more
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Lead the development and delivery of training on case processing, safety reporting , and relevant regulatory guidelines (FDA, EMA, ICH) Conduct regular ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations. This… more
- Merck & Co. (Upper Gwynedd, PA)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting , and publication. -- Responsibilities: Specifically, the ... science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology Clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our ... own the roadmap and governance for Finance, Digital Payments, and SAP reporting /analytics platforms (BW/HANA), and will partner closely with Finance, IT, Operations… more
- Merck & Co. (Boston, MA)
- …strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting , and publication.Specifically, the Senior Director May Be ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …together to change lives for the better. The Position The Associate Director , Consumer Social Media Strategy is a high-impact, hands-on leadership role responsible ... role translates the corporate digital vision set by the Senior Director into best-in-class digital experiences, driving audience engagement, building brand trust,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance ... with Global PV regulations for individual case safety and periodic reporting . Serves as the key DSI contact for PV service providers to address, escalate issues… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …privacy, compliance and legal. Relationships The position reports to the Director , Patient Solutions and Field Reimbursement. Closely partners closely with MAPA, ... training development, development of SBOs/KPIs, execution and oversight Partner with Director to implement and execute launch planning strategies, defines and drives… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work together to change lives for the better. The Position The Associate Director , Media Relations & Issues Management is accountable for establishing and leading ... potential to dramatically influence stakeholder perceptions. Relationships Reports to the Director , Media & Stakeholder Relations, and interacts with senior leaders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Relationships This position reports into a Vice President or Sr. Director within the National Account Market Access Teams. Internally, this position has ... pricing implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds a broad… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleGenmab is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an ... impact Medical Affairs team, and work in a highly dynamic and collaborative setting.The Director , HEOL Team Lead is part of the US Field Medical Affairs leadership… more
- Novo Nordisk Inc. (Boulder, CO)
- …both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product ... manage their own projects. Relationships This position reports to the Executive Director , Manufacturing. Essential Functions Lead, manage, and advise all aspects of… more
