- 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)
- …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)
- …within the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management ... implementing risk control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant standards. Ensure alignment with… more
- Merck & Co. (Rahway, NJ)
- …livestock (beef, dairy, swine, poultry, aquaculture). Reporting to the Executive Director , Channel Operations & Engagement, you will connect brand teams, ... marketing teams within the organization along with sales, product development, regulatory affairs, customer service, and other cross-functional teams to ensure an… 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)
- …Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Submissions ... affairs, to ensure comprehensive biophysical characterization of products.Ensure compliance with regulatory guidelines and industry standards related… 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
- 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)
- …Automation, Process Optimization, Product Formulation, Project Management, Quality Control Management, Regulatory Compliance , Regulatory Issues, Safety ... and equipment performance to ensure robust operation while maintaining compliance with all current regulatory expectations.-Receives assignments, direction,… 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
- 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)
- …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
- 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
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic ... clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving… more
- Merck & Co. (Rahway, NJ)
- …Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance , Regulatory Compliance , Scientific Leadership, Scientific ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Merck & Co. (Rahway, NJ)
- …Drug Development, Gastroenterology, Inflammatory Bowel Diseases, Pharmaceutical Industry, Regulatory Compliance , RheumatologyPreferred Skills: Current Employees ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Merck & Co. (Rahway, NJ)
- …and outcomes while maintaining compliance with the highest ethical and regulatory standards.- The Director will collaborate closely with the US patient ... Job Description Director Global Marketing Immunology - IBD Patient Strategy...with global and ex-U.S. commercial, medical, access, policy, and compliance stakeholders to ensure that Therapy Patient Programs (TPPs)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment, ... Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Senior Director of Quality Operations as part of the Quality team based in Raritan, ... NJ.Role OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities...United States and ensure the sites operate in full compliance with established cGMP requirements. This individual will be… more
