- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- Merck & Co. (Boston, MA)
- …West Point, PA / Rahway, NJ is seeking a curious and collaborative Senior Scientist to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - ... As a senior specialist you will be part of a cr...independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. Educational background in biopharmaceutics, pharmaceutical… more
- Merck & Co. (South San Francisco, CA)
- …AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role ... Metabolism, and Bioanalytics (PDMB) department of Research Laboratories is seeking a Senior Scientist specializing in AI/ML to support efforts in transforming the… more
- Merck & Co. (Upper Gwynedd, PA)
- …Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory ... 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)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... partners to achieve strategic business goals. Preferred Experience: Working knowledge of regulatory requirements and standards (21 CFR Part 4, 21 CFR Part 820,… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company Research… more
- Merck & Co. (Rahway, NJ)
- Job Description Senior Principal Scientist Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for ... point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the… more
- Merck & Co. (Rahway, NJ)
- …other related function areas. Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Merck & Co. (North Wales, PA)
- …the organization with the mission to achieve business excellence. The RCLO Senior Specialist is responsible for supporting and improving the processes for creation ... of promotional resources for customers and patients.The RCLO Senior Specialist will have a growth mindset and be able to quickly assess needs and propose and… more
- Merck & Co. (Rahway, NJ)
- …in Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication ... selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Tris Pharma (Monmouth Junction, NJ)
- …negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory ... control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality, and regulatory standards in warehouse… more
- Repligen (Waltham, MA)
- …reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure compliance with accounting standards and regulatory requirements, including SEC ... public company is looking for a strong, experienced, and technically sound Senior Director, Assistant Controller, who will own the Company's accounting processes… more
- Eisai, Inc (Nutley, NJ)
- …price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and day-to-day legal support, ... support, patient assistance programs, adherence support).Works to ensure Eisai's compliance with pharmaceutical laws and industry guidelines including the… more
- Tris Pharma (Monmouth Junction, NJ)
- …incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively, ... Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations, etc. Responsibilities:Assures compliance … 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, ... IT teams to ensure a strong data and technology foundation Engage senior leaders to drive strategic technology transformations Physical Requirements 10-20% overnight… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Senior Manager, Patient Support Data Intelligence is responsible for process improvement, technology, ... NovoCare® Patient Support Programs. Management of relevant data sets include compliance and database information integrity, program tracking, metrics, analysis, and… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. - The incumbant is responsible… more
