- Novo Nordisk Inc. (Plainsboro, NJ)
- …NNI departments, including but not limited to Medical, Regulatory, Marketing, Sales, Commercial Operations, and Ethics, Compliance & Privacy. May interact with ... and industry standards. Relationships Acts as Counsel on the Clinical Commercial and Corporate Law team. Interacts with department colleagues and individuals… more
- Merck & Co. (Rahway, NJ)
- …and business environment, including:API and Drug Product development needsGMP compliance in commercial manufacturingData integrity principlesCoach and mentor ... investigations with a strong focus on quality and regulatory compliance .Excel in impurity isolation, unknown peak identification, characterization of degradation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across the Novo Nordisk US Operations, including ED&AA, IT, Ethics and Compliance , Commercial , Patient Services, CMR (Clinical, Medical, Regulatory), Finance, ... and Novo Nordisk global colleagues. Externally, this role interacts with and manages various vendors. Essential Functions Leadership and Management Skilled communicator and collaborator with influence across functions Strong business acumen; trusted advisor on… more
- Eisai, Inc (Raleigh, NC)
- …you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh ... area: Review manufacturing batch records for completeness, accuracy, and compliance with procedures to support timely product lot disposition.Maintain associated… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access and Public Affairs (MAPA), Customer Engagement and Integrated Solutions, Commercial Excellence, Legal, Regulatory Affairs, Compliance and other relevant ... About the Department The Rare Disease organization leads all US Commercial efforts for Novo Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes… more
- Lundbeck (Fresno, CA)
- …and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial ) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability ... to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and… more
- Merck & Co. (Rahway, NJ)
- …of new formulations and development of robust and scalable processes for commercial products. The applicant will preferably have experience with high concentration ... biologics to support clinical and commercial development. Maintaining a strong network internally and across...as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Affairs Team, PCOR (Pricing, Contracting, Operations and Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External ... years pharmaceutical/biotech industry experience required, 5 of which were in a commercial or sales-related function A Minimum of 6 years successful account… more
- Lundbeck (Waco, TX)
- …and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial ) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply ... knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS:… more
- Merck & Co. (Rahway, NJ)
- …pricing strategy, and payer/stakeholder communication tools in collaboration with Commercial , Clinical Development, Outcomes Research, Medical Affairs, Policy and ... considerations are integrated into asset development plans. including clinical and commercial , taking informed positions related to price, value and affordability… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …prior industry experience to optimize resource allocation, ensure regulatory compliance , and uphold rigorous scientific standards. Understanding best industry ... Drive business growth by initiating and nurturing collaborations with commercial research partners. Cultivate relationships with clients and stakeholders to… more
- Merck & Co. (Rahway, NJ)
- …daily operations, troubleshooting, and optimization of HVAC systems for both commercial office buildings and pharmaceutical laboratories at the Rahway, NJ ... Site.Develop, implement, and maintain HVAC operational strategies that ensure compliance with GxP (as applicable) and other regulatory requirements.Lead the… more
- Novo Nordisk Inc. (Denver, CO)
- About the Department The Rare Disease organization leads all US Commercial efforts for Novo Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes ... Sales Organization, Peer Community Liaison Leaders, Government Affairs team, Commercial Excellence, Marketing, and other internal stakeholders. External relationships… more
- Merck & Co. (Rahway, NJ)
- …test methods, and robust manufacturing processes for both clinical and commercial use. This position interacts extensively with subject-matter experts within the ... and risk management techniques to positively support and influence clinical and commercial combination product development and launches. The incumbent must also be… more
- Merck & Co. (Rahway, NJ)
- …boundaries and ground rules for engagement with the EPs, while ensuring compliance /quality readiness of these suppliers at all times through the implementation of ... to, purchase orders, forecasts, deliveries, and invoice payments are executed in compliance with the Supply AgreementPartners with the ExM Company Production System… more
- Merck & Co. (KY)
- …Context:This position is an individual contributor role.Animal Health Commercial CompetenciesLeadership BehaviorsDemonstrate Ethics & IntegrityDrive ResultsFocus on ... & Financial AcumenWorking Across BoundariesStrategic ThinkingProductive CommunicationProblem SolvingProject ManagementCore Commercial Functional Competencies Customer and Market InsightsProduct Knowledge &… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP environment.Key Responsibilities ... organizational design updates, operations organization build, operations ramp-up of commercial and clinical capacity.Build strong partnerships with Manufacturing, Supply… more
- Merck & Co. (Rahway, NJ)
- …skilled individual to lead the charge in transforming our late-stage pipeline and commercial products into reality.What You'll Do:As a key player in our BDSC team, ... portfolio.Drive Innovation: Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments, analyze… more
- Merck & Co. (Rahway, NJ)
- …completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses. -The senior programmer will also write programs ... analyze data with statistical methods which are not currently available through commercial software packages. The senior programmer will be a key collaborator with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to provide key insights into the biopharmaceutical landscape across clinical, commercial , and enterprise domains. This role involves applying data interpretation and ... to identify market trends, leading a high-performing team while ensuring compliance with legal standards. The Director will drive informed decision-making and… more
