- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across GOMA Fluent in English Must be willing to comply with all regulatory / compliance policies Interest in Pharma industryDaiichi Sankyo, Inc. is an equal ... a Publications Systems and Operations Intern to work closely with the Director of Publications Operations to optimize department resources for delivery of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. ... as well as with all applicable regulatory requirements.Support GxP regulatory inspections as required.Support the local Compliance and auditing teams… more
- Merck & Co. (Rahway, NJ)
- …Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5 more}Preferred Skills: Current ... science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology Clinical… more
- Merck & Co. (Rahway, NJ)
- …Name Development, Process Improvements, Professional Presentation, Project Management, Regulatory Compliance , Strategic PlanningPreferred Skills: Current ... the brand while ensuring adherence to internal processes and regulatory guidelines.- To prepare for these launches, we are...for these launches, we are looking for an Associate Director (AD) to join our center of excellence.Description:-Under the… more
- Merck & Co. (Rahway, NJ)
- …DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) Team ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...to all appropriate departments in Formation Bio to assure compliance with applicable regulations. Remains knowledgeable about current regulations… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- … compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.Ability to travel globally approximately 20-30% of the ... improvement experienceRequired Skills: Audit Readiness, Drug Product Manufacturing, FDA Compliance , FDA GMP, FDA Inspections, FDA Regulatory Requirements,… more
- Formation Bio (New York, NY)
- …vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and ... review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, and… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional… more
- Merck & Co. (Rahway, NJ)
- …Program Management, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk Management, Stakeholder ManagementPreferred Skills: ... Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across...of the Value Chain Management Team, guiding strategy, ensuring compliance , and enabling manufacturing excellence from development through commercialization.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational leader...and systems support business goals and comply with safety, regulatory , and sustainability standards. This position is a key… 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 ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs ... development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and design… more
- Merck & Co. (Rahway, NJ)
- …are currently seeking a Cardiovascular & Respiratory Competitive Intelligence Director specializing in PAH, COPD, and other cardiopulmonary diseases. This ... comprehensive understanding of relevant healthcare environment matters, including policy, regulatory , and health technologyDeveloping a global internal network of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This role ... principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF strategy, foster cross-functional collaboration, and… more
