- 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
- Eisai, Inc (New York, NY)
- …specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner ... to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in… 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)
- …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
- Eisai, Inc (Nutley, NJ)
- …performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance frameworks, and compliance with ... with a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and executes outsourcing… more
- Eisai, Inc (Nutley, NJ)
- …and compliance with Eisai policies and procedures and applicable regulatory authority directives and regulations. Analyze competitor labeling and ensure Eisai ... your profile, we want to hear from you. The Director , Global Labeling is responsible for the leadership and...leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the guidance of an Executive Director , within the Value and Implementation (V&) Outcomes Research Pneumococcal Vaccines team the incumbent has ... plans for our company's in-line and developmental products based on the regulatory , marketing and reimbursement environments on a worldwide basis, including the… 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)
- …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)
- …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)
- …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)
- …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)
- …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)
- 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)
- …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
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there’s only one choice. Senior Director , Digital Governance & LMR Lead The Senior Director , Digital Governance & ... via enhanced strategic USMA Governance, proactively oversees the local Legal-Medical- Regulatory approval procedures and ensures maximal effectiveness while mitigating… 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)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for the...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
