- Formation Bio (New York, NY)
- …mission to bring new treatments to patients faster and more efficiently.About the PositionThe Director , Quality Management Systems plays a pivotal role in ... and continuous improvement of an effective, compliant and 'fit for purpose' quality management system (QMS) ensuring Formation Bio is in a phase appropriate,… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading and ... executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial Managers (CTMs) and Clinical… more
- Formation Bio (New York, NY)
- …and implement corrective and preventive actions (CAPA effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root ... to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the...cause analysis, FMEA) and quality management software systems. Veev experience preferred.… more
- Formation Bio (New York, NY)
- …the PositionFormation Bio is seeking a highly skilled and experienced Senior Director , Biostatistics to join our dynamic team. This critical role will report ... and leveraging biostatistics to advance our drug development processes.The Senior Director , Biostatistics will play a key role in shaping innovative trial… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionAs Director , Product Design at Formation Bio, your primary focus will be translating ... and stakeholders Develop and implement best practices for Design productivity, quality , and cross-functional collaboration People Lead the Product Design team in… more
- Merck & Co. (Rahway, NJ)
- …combination products, demonstrating a deep understanding of regulatory frameworks, quality management systems, and industry best practices.Exceptional strategic ... Job DescriptionThe Executive Director , Device Technical Operations is a pivotal leadership...is accountable for ensuring each inline team has robust lifecycle- management plans, appropriate and rigorous technical support processes to… more
- Merck & Co. (Rahway, NJ)
- …with all groups within GCTO, especially with Clinical-Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs) and Regional-Operations Teams, ... Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in...GCP, local and global policies and procedures to conduct high- quality , inspection ready-studies is essential. The position is accountable… more
- Merck & Co. (Rahway, NJ)
- Job Description Product Manager , Trial and Site Management Product Line - - Job Description - - Our Company Research Labs IT team partners with the Clinical Trial ... and passionate P roduct Manager for Trial and Site Management P roduct L ine to own the product...closely with software engineers , UX designers, data engineers, quality engineers and other product teams and product leadership… more
- Merck & Co. (Rahway, NJ)
- …vaccines.- We deliver critical building and site services, including facility management , emergency response, utilities (including electricity and water), and real ... data collection systems and other strategies that-optimize-statistical efficiency and quality .Develop and-maintain-Site Facility Energy Regression models.Work with Operations and… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …journey to become the premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the ... HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving shaping and delivery of impactful solutions that enable… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO ... 14971, EU MDR, ISO 11608 Needle-based injection system for medical use.Familiarity with Design Verification (DV) strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO ... 14971, EU MDR, ISO 11608 Needle-based injection system for medical use.Familiarity with Design Verification (DV) strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation… more
- Merck & Co. (Rahway, NJ)
- …responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.The Director , Nuclear Magnetic Resonance Lead, is ... Analytical Enabling Capabilities Department has an exciting opportunity for a Director of Nuclear Magnetic Resonance (NMR).- The NMR Lead provides strategic… more
- Merck & Co. (Rahway, NJ)
- …therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… more
- Merck & Co. (Rahway, NJ)
- …self-awareness and build trust through effective communication and relationship management .Execution Excellence: Deliver high- quality outputs within deadlines ... is focused on delivering exceptional performance in value creation, supplier management , and risk mitigation through strategic sourcing initiatives for Human… more
- Merck & Co. (Rahway, NJ)
- …requirements by their strong scientific background, excellent communications skills, and project management skills to derive high- quality reference data to meet ... Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is...nomenclatureLeading nomenclature and reference data projects or other data management tasksFacilitating timely delivery of high- quality scientific… more
- Merck & Co. (Rahway, NJ)
- …DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development Team designs, ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Merck & Co. (Rahway, NJ)
- …value evidence strategies for in-line and pipeline products. Obtain senior management approval of value evidence generation plans. Provide outcomes research ... presentations, and publications.Responsible for study-related contracting, budgets, and vendor/partner management .Develop American Managed Care Pharmacy (AMCP) dossiers for US… more
