- Merck & Co. (Rahway, NJ)
- …the US improve patient experience, treatment adherence, and outcomes while maintaining compliance with the highest ethical and regulatory standards.- The ... with global and ex-U.S. commercial, medical, access, policy, and compliance stakeholders to ensure that Therapy Patient Programs (TPPs)...Director will collaborate closely with the US patient support strategy (PSP) lead where relevant, with an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Strategy and Study Execution while exhibiting leadership qualities.Responsibilities- - Lead the core study team while project managing and collaborating with ... areas centered around rare diseases and immune disorders. SummaryThe Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team… more
- Merck & Co. (Rahway, NJ)
- …within the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management ... Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team,...and post-market evaluation.Develop and execute the device risk management strategy , including the creation of device risk management plans… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... Responsibilities: Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from… more
- Eisai, Inc (Nutley, NJ)
- …with a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and executes outsourcing ... across the organization. Collaboration is central, working closely with Finance, Legal, Regulatory & Compliance , IT Security, and Clinical teams to align… more
- Merck & Co. (Rahway, NJ)
- …regulatory , company, and customer requirements. - Principal Responsibilities Lead /Support continuous improvement initiatives for design control and risk ... to improve processes related to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations.… more
- Merck & Co. (Rahway, NJ)
- …for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial product.-The specific role will ... DCT deliverables including - robust processes & analytics, an integrated control strategy , successful tech transfer packages, filing and approval, and a robust… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deemed necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or ... audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment,… more
- Merck & Co. (Rahway, NJ)
- …experience-driven omnichannel engine across our US Animal Health portfolio. You will lead a team that owns digital demand creation and customer experience for ... may include, but are not limited to: -- Strategic Planning Communications: Lead the development and implementation of digital marketing plans to achieve business… more
- Merck & Co. (Rahway, NJ)
- …based on the business value and technical complexity of the IT solutions.ResponsibilitiesProduct Strategy & Roadmap Lead the applications under the Product and ... Management background to help us shape the vision and strategy of our software products in the clinical domain.The...solutions that improve how we run clinical trials and regulatory submission for our patients, partners, and colleagues.As a… more
- Merck & Co. (Rahway, NJ)
- …Analytical Technology (PAT), Process Scale Up, Regulatory Compliance , Scientific Innovation, Strategic Leadership, Strategy Implementation, Technology ... enzymes.As a senior scientific leader, the successful candidate will shape strategy , drive innovation, and ensure robust, scalable, and compliant microbial… more
- Eisai, Inc (Nutley, NJ)
- …to work independently and not require close supervision while adhering to compliance / regulatory policies. Interest in leading and participating in projects while ... with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet...congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL… more
- Merck & Co. (Rahway, NJ)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... biomarker platforms.Development and execution of the early clinical development strategy for novel therapy/Immunology programs from Preclinical Candidate approval… more
- Merck & Co. (Rahway, NJ)
- …scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical ... of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence… more
- Merck & Co. (Rahway, NJ)
- …Clinical Development and Digital Solutions (CDDS) value team, the Business Strategy Partnership (BSP) organization is seeking a highly motivated Senior Specialist ... accessibility across the complex clinical development ecosystem. Reporting to the BIA team lead , the Senior Specialist / Information Architect will play a key role… more
- Lundbeck (Jersey City, NJ)
- …issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical and regulatory ... in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with… more
- AbbVie (Florham Park, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director, Regulatory Affairs Global Regulatory Strategy is responsible ... Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST). Serves as the...Sr GRL or TA Head. May participate in or lead regulatory and company initiatives. Based on… more
- Reckitt (Parsippany, NJ)
- …you to grow in our great organisation. **About the role** + Lead Global Regulatory & Safety (RAS) strategy for the Specialty & Allergy category and act as ... on category strategy . + Support the RAS Strategy Lead in non-innovation workstreams. + Mentor...actionable strategies. + Passion for nutrition and commitment to compliance excellence. + Expertise in regulatory tools… more
- Sanofi Group (Morristown, NJ)
- … impact assessments for proposed product changes + May serve as a regional/local regulatory lead and point of contact with medical deviceHealth Authorities for ... Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT,...prioritization, objectives and setting clear expectations for the device regulatory strategy , including a global labeling … more
