- Merck & Co. (Rahway, NJ)
- …to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director, Lead of Strategy for Device Product Assessment & Innovation will define and ... cross-functional processes that drive efficient, discovery facing innovations and decision-making strategy for all elements of early development. They will lead… more
- Merck & Co. (Rahway, NJ)
- … precedence, and competitive intelligence to facilitate development of regulatory strategy .Assisting the global regulatory lead in authoring of ... attending Agency meetings as needed to assist the global regulatory lead .Participating as an active member on...regulatory strategy documents.Collaborating and communicating regulatory strategy to colleagues in Regulatory… more
- Merck & Co. (Rahway, NJ)
- …and investment cases to deliver enterprise value, focusing on innovation, risk, regulatory compliance , and scalability. Act as a senior technology business ... Management, Product Management Leadership, Product Strategies, Regulatory Affairs Compliance , Regulatory Compliance , Requirements Management, Stakeholder… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …per TA. Partners compliantly with respective home office functions, including Commercial Strategy and Marketing, Insights & Analytics, privacy, compliance and ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Parexel (Trenton, NJ)
- **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a strategic thinker with a passion for navigating the complex world of global ... plans? If so, we'd love to connect. We are seeking a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contract lobbyists and customers, as necessary. Internal relationships include Legal, Compliance , Managed Markets Sales & Strategy , BioPharm, Medical, ... ready to realize your potential? The Position The Regional Lead of State Government Affairs sits within the State...state government affairs goals that advance Novo Nordisk's enterprise strategy as it relates to state legislation and policy.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPut marketing strategy into action as you lead the development of our customer experience and campaign planning. Leveraging your strong ... insights, you'll shape and orchestrate fully integrated digital campaigns and confidently lead our agency and internal teams through the creative process for… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the implementation of the quality strategy in alignment with ... of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process for reviewing and assessing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …content of any documents sent to regulatory authorities. Provides compliance metrics to management, as needed. Lead continuous improvement around development ... across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a...to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance… 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
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance , Medical Affairs, Market Access, and Commercial ... be responsible for shaping and executing the professional and payer marketing strategy to ensure successful US launch readiness and long-term adoption. This role… more
- Insmed Incorporated (NJ)
- …teams and external partners. The position is critical in shaping quality strategy , managing risk, and supporting regulatory readiness for complex, evolving ... providing expert input on GMP requirements and ensuring alignment with global Quality strategy . Lead and develop a team of 2-8 Quality professionals supporting… more
- Merck & Co. (Rahway, NJ)
- …including method development and validation, internally or externally, per design verification strategy . Lead strategy and execution of accelerated and real ... Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our… more
- Merck & Co. (Rahway, NJ)
- …R5-equivalent - About the role We are hiring a Senior Product Manager to lead strategic development of our Integrated Printing and Plastic Manufacturing system - a ... and automation/controls. You will set the product vision, align multi-year strategy with executive priorities, and partner closely with manufacturing leadership,… more
- Merck & Co. (Rahway, NJ)
- …Networking and Partnerships, Program Management, Quality Management Systems (QMS), Quality Strategy , Regulatory Compliance , Risk Management, Stakeholder ... DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a...core member of the Value Chain Management Team, guiding strategy , ensuring compliance , and enabling manufacturing excellence… 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
- 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)
- …not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of clinical development, as well as ... for commercialization and in line commercial projects. Lead development and implementation of robust non-GMP characterization methods, using quality by design… more
