- Merck & Co. (Rahway, NJ)
- … Affairs Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine ... as the single, accountable, global point of contact on those projects.Develops global regulatory strategy for their assigned products, to optimize labeling and… more
- Merck & Co. (Rahway, NJ)
- … Affairs Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine ... Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more company investigational… more
- Merck & Co. (Rahway, NJ)
- …strategic direction of the company's product pipeline and regulatory strategy .Drive operational excellence initiatives that improve quality, compliance , and ... and implement continuous improvement strategies for device quality and regulatory processes.Monitor and ensure compliance with global regulations… more
- Merck & Co. (Rahway, NJ)
- …other parts of the AR&D organization in aspects of quality control and compliance . Your main responsibilities will include: - Strategy and Operational ... exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience...needs, which can include impact of the external business, regulatory , and compliance environment. Promoting our company's… more
- Merck & Co. (Rahway, NJ)
- …of the following: process performance qualification, risk assessment, control strategy , process comparability reports, and/or regulatory submissions.Adaptability ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Merck & Co. (Rahway, NJ)
- …modalities for clinical and/or commercial manufacturing would be idealExperience in regulatory compliance expectations across all phases of product development ... (SPD) team. The successful candidate will be expected to lead the team focused on the design of new...formulation and process development and document technical reports and regulatory filings. The successful candidate will be key in… more
- Merck & Co. (Rahway, NJ)
- …support development, IND-enabling stability, commercial stability (PSS), and Design Verification (DV). Lead method tech transfer strategy and execution to ... stability, and Design Verification. This role involves leading the method tech transfer strategy and execution to internal and external GMP testing nodes in support… more
- Merck & Co. (Rahway, NJ)
- …for delivering a fully integrated stage-appropriate development and commercialization strategy which yields the target commercial product.-Leads the cross-functional ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Merck & Co. (Rahway, NJ)
- …of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering… more
- Merck & Co. (Rahway, NJ)
- …contributor, shape and realize innovation across the Biologics' pipeline, strategy , and scienceAdvance the pipeline by collaborating with cross-functional teams, ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable purification processes for… more
- Merck & Co. (Rahway, NJ)
- …from individuals around the world.The future incumbent of this position ensures regulatory compliance and operational excellence by managing the DSR process ... on best practices and optimal DSR service models, ensuring process readiness for regulatory compliance .DSR Process & Technology: defines the plan for the global… more
- Merck & Co. (Rahway, NJ)
- …Lung cancer for our Company's oncology business.- The Global Marketing Director will lead strategies and marketing efforts for Non-small Cell Lung Cancer (NSCLC) and ... thought leader engagements, medical symposia, webcasts, and speaker forumsLung Disease lead for the evolution of the organization's Early Detection / Screening… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal driver in shaping an ... brand/therapy area vision and message. Relationships Reports to the Integrated TA Strategy Lead . Responsible for providing interface with key internal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …into actionable marketing strategies to guide customer experiences Understanding of regulatory , compliance , and ethical considerations in engaging with ... About the Department Our Commercial Strategy and Marketing group creates and delivers human-centered...to experiment with us? The Position The CX Functional Lead is responsible for developing and executing MarTech strategies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …play a critical role in partnering with other NNI teams to drive health systems strategy Regulatory and Compliance Alignment: Ensure that all aspects of the ... diagnostic and precision health strategy align with regulatory requirements and compliance standards. Collaborate with regulatory affairs and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Eisai, Inc (Nutley, NJ)
- …assesses and provides objective risk assessments and guidance regarding Eisai's compliance with regulatory , organizational, and commercial requirements that ... compliance initiatives (strategic and execution).Assess and guide on compliance with regulatory , organizational, and commercial requirements.Define and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …, Insights and Analytics, IT, Data Strategy , Commercial Excellence, Legal, Compliance , Privacy, Regulatory Affairs, and other relevant NNI departments to ... that stakeholders on both are in alignment related to strategy , execution, compliance , privacy and legal matters....alignment with TA objectives and strategies. Essential Functions 5D Strategy and Execution Lead the development and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Area Lead is to develop and implement a comprehensive strategy for designing and orchestrating Therapeutic Area (TA) specific customer experience activation ... enhance TA-specific customer experiences; building strong cross-functional relationships; ensuring compliance to Legal, Regulatory and industry standards;… more
