- Merck & Co. (Rahway, NJ)
- …for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Eisai, Inc (Nutley, NJ)
- …sales/business analytics) preferred.Experience working with pharmaceutical manufacturer compliance & regulatory requirements preferred.Experience navigating ... will have the primary role of demand generation by conveying complex clinical information to customers and key stakeholders consistent with the FDA-approved… more
- Eisai, Inc (Raleigh, NC)
- …QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. ... is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to… more
- Merck & Co. (Omaha, NE)
- …time. -We are seeking a Growth and Improvement minded Associate Specialist , Logistics who can help drive our Strategic Operating Priorities.Strategic SummaryThe ... Associate Logistics Specialist will be responsible for export of raw materials...closely with freight forwarders, QA departments, USDA and other regulatory officers. Provide data to the Finance department so… more
- Aequor (Thousand Oaks, CA)
- …of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting ... and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network… more
- Merck & Co. (Rahway, NJ)
- …Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations.Current ... biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile Process… more
- Eisai, Inc (Phoenix, AZ)
- …promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and management ... profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology therapeutic… more
- Merck & Co. (Rahway, NJ)
- …Procurement, Procurement Management, Production Planning, Project Procurement Management, Regulatory Compliance , Risk Management, Stakeholder Engagement, ... Global Workspace and Enterprise Services (GWES) and our research laboratories, Global Clinical Development for Southeast and part of Northeast US. This position will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, or cell therapy.Knowledge of cGMP regulations ... treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist III as part of the Quality team based...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Abbott (Santa Clara, CA)
- …communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance . Premarket: Assess the acceptability of quality, ... catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out… more
- Boston Scientific (Maple Grove, MN)
- …applications and post-market studies Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings ... and labeling reviews of supporting documents for inclusion in regulatory filings Review of clinical study protocols and other clinical documentation, and… more
- Conmed (Denver, CO)
- … Affairs Specialist plays a critical role in ensuring regulatory compliance and supporting cross-functional teams in the preparation, submission, ... quality, clinical , legal, commercial, and reimbursement teams to align regulatory strategies. Identify regulatory submission and approval requirements, and… more
- Smith & Nephew (Pittsburgh, PA)
- Principal Regulatory Specialist , Robotics (Pittsburgh, PA) Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off ... regulatory authorities as required Review and approve product labeling to ensure compliance with regulatory requirements What will you need to be successful?… more
- Boston Scientific (Maple Grove, MN)
- …pipeline, and we will continue to make an investment in Interventional treatments. This Regulatory Affairs Specialist II role will be a part of the ... devices. In this role you will participate in activities to ensure compliance with worldwide regulatory requirements. Your responsibilities include: Acts as… more
- Katalyst HealthCares and Life Sciences (Alameda, CA)
- …and app-based devices (Annex I & XIII). Effective collaboration with software, clinical , and human factors team. Post-market compliance expertise, including UDI, ... Responsibilities: Responsibilities include developing regulatory strategies, reviewing design input/output documentation, identification of applicable standards and… more
- Intuitive (Sunnyvale, CA)
- …impact of clinical strategy and design inputs and outputs on regulatory filings and compliance . Create awareness within the organization regarding ... and significant product changes in a timely manner. Support clinical study strategy and design as it relates to... Engineer] or in a Science field (preferable) [Sr. Regulatory Specialist ] Experience: Minimum 5 years relevant… more
- Boston Scientific (Marlborough, MA)
- …responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering ... Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations. Interact with regulatory agencies as… more
- Kaiser Permanente (Los Angeles, CA)
- …verifying and documenting expirables using acceptable verification sources to ensure compliance with accreditation and regulatory standards, with occasional ... ways to address improvement opportunities for team. Participates in training and regulatory awareness by: may be assisting in the facilitation of orientation and… more
- Pennsylvania Medicine (Elizabethtown, PA)
- …imaging or heath information management team with in the established time frames. Compliance Regulatory Completes documentation for compliance and ... experience, point of service collection, insurance validation, understanding of compliance regulatory guidelines and order release process(es). (Preferred)… more
- Monument Health (Rapid City, SD)
- …and referral records to confirm financial clearance. Educates patient and maintains regulatory compliance as required by distributing and/or obtaining required ... you will do each day. As a Patient Access Specialist I at Monument Health, you can begin your...consents for treatment and financial agreements, ABN/waivers, and other regulatory forms. Performs business office duties including incoming phone… more
