- Merck & Co. (Rahway, NJ)
- …regulatory content Understanding of CMC operations, technology transfer, control strategy development, and regulatory authoring requirements that inform ... and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The Director, Key Opinion Leader Strategy & Engagement will lead a team and critically shape KOL strategy ... and launch KOL- and association-related brand/therapy area strategic objectives KOL Experience Strategy : Lead the execution of KOL experience strategies and… 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
- 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
- Genmab (NJ)
- …and adherence to corporate complianceCurrent working knowledge of US-specific legal, regulatory , and compliance regulations and guidelines relevant to industry ... a Director, HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an exciting, passionate,...responsible for the execution of the US Medical Affairs strategy in support of the US business objectives. The… 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)
- …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
- 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
- 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
- Insmed Incorporated (NJ)
- …of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product ... CTAs).Work with the ED of DSPV to develop the strategy and implementation of safety and benefit-risk management for... authorities on safety issues for assigned products and lead the integrated safety input into all regulatory… more
- Insmed Incorporated (NJ)
- …for content and positioning) and represent content during medical, legal, and regulatory review.With Medical Excellence, lead training of Medical Affairs teams ... the Role:We're looking for a Director, Scientific Communications on the Medical Strategy and Communications team to help us expand what's possible for patients… more
- Insmed Incorporated (NJ)
- …Operations leadership team and contribute significantly to our overall product development strategy .You'll lead both drug substance (API) and drug product ... with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (CMC) activities for the company's small… 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
- Insmed Incorporated (NJ)
- …(CSV) program. This role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The ... mitigation strategies CSV Program Oversight: Oversee the CSV team, validation strategy and continuous process improvementEnsure compliance with GxP regulations… more
- Insmed Incorporated (NJ)
- …alignment of US HCP activities with field execution.Work closely with Legal, Regulatory , Compliance , Medical Affairs, Market Access, and Commercial Operations ... (PPF) will be responsible for shaping and executing the professional marketing strategy to ensure successful US launch readiness and long-term adoption. This role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Rare Disease), as well as with internal stakeholders (Government Contracts & Compliance , Rebate Operations and Insights, Market Access Strategy , Legal, and ... Kaiser, institutions, GPOs) and other area/regional accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes… 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
- 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
