- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in… more
- Merck & Co. (Rahway, NJ)
- …Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new...drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as… more
- Merck & Co. (Rahway, NJ)
- …inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This ... controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and… more
- Merck & Co. (Rahway, NJ)
- …Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance , Regulatory Reporting, ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Merck & Co. (Rahway, NJ)
- …Safety, Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support , Pharmaceutical Manufacturing, Regulatory Compliance , ... matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in… more
- Merck & Co. (Durham, NC)
- …Operational Excellence, Process Optimization, Process Troubleshooting, Production Operations, Production Support , Project Management, Regulatory Compliance , ... routine process support , projects, and improvement activitiesServing as subject matter expert on the process for daily work and projects, understand full process… more
- Merck & Co. (Rahway, NJ)
- …PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our robust infectious disease and vaccines pipeline. - As an Associate Director, ... a quantitative drug developer taking advantage of our end-to-end pipeline support in one of the world's most research-intensive biopharmaceutical companies.… more
- Eisai, Inc (Raleigh, NC)
- …of deviations or events on product quality. \tActing as a Subject Matter Expert (SME) during regulatory inspections in assigned area(s) of responsibility.This ... Quality area: Review manufacturing batch records for completeness, accuracy, and compliance with procedures to support timely product lot disposition.Maintain… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... implement robust reporting, analytics, and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation:… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Aequor (Pearl River, LA)
- …experimental results and present at team meetings. Write research reports to support regulatory submissions. Read scientific and technical literature to stay ... quality. You will be part of a team to support the preclinical evaluation and clinical development of mRNA...improved technologies to the laboratory. Maintain laboratory notebooks in compliance with the Laboratory Notebook Policy. Stay current on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that all content, community interactions, and account activities comply with legal, regulatory , and corporate standards.- Collaborate with legal, compliance , and ... aligns with both global objectives and local market needs.- Serve as the go-to expert for LinkedIn governance, providing support and guidance to internal teams… more
- Merck & Co. (North Wales, PA)
- …Vaccine Clinical Development TA.May serve as a senior therapeutic area content expert within the company, providing input into research and business development ... the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
- Merck & Co. (North Wales, PA)
- …development of project management, communication, and collaboration skills in support of our clinical trials.Job ResponsibilitiesResponsible for the operational ... stakeholders (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor… more
- Merck & Co. (North Wales, PA)
- …the following responsibilities:1.) development of the integrated evidence strategy to support HTA/ reimbursement/ NITAG evaluations; 2.) development of overall Real ... OR planning process and generates data on a worldwide basis to support pricing and reimbursement.Develops value evidence deliverables (eg, global value dossier,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for EBR development and administration at the Raritan site to support production processing while liaising with other functions including but not limited ... to Tech Support , Process Improvement, Validation, Supply Chain, Operations, QA, Reg...planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External relationships include Customers as outlined in the Purpose of ... role maintains relationships with other associations, organizations, and patient support partners. Essential Functions Individual is a strong collaborator across… more
- Eisai, Inc (Nutley, NJ)
- …and provide input into CME budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical ... therapeutic area(s) .Serve as the medical education subject matter expert and strategic partner on cross-functional medical teams, providing...industry, and to ensure compliance with Eisai policies & procedures.Provide support … more
- USAA (Phoenix, AZ)
- …business requirements for identified solutions. Directs and oversees multiple initiatives in support of Underwriting and/or regulatory compliance related ... processes and programs while balancing operational efficiency, competitiveness, and regulatory compliance . Implementation may include overseeing business… more
