- Bausch + Lomb (Columbus, OH)
- …advancement of eye health in the future. **Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and ... US regulatory licensing. **Responsibilities** + Proactively communicate CMC regulatory strategy, key issues and any...project teams and to appropriate management level in Regulatory Affairs, R&D, TechOps and Supply Chain as appropriate… more
- West Pharmaceutical Services (Exton, PA)
- Sr. Specialist , Regulatory Project Mgmt...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical ... environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist , Regulatory Project Management (RPM) role is responsible… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …with internal and external key stakeholders: including Chemistry Manufacturing and Controls ( CMC ) team members and Contract Research Organizations (CROs), as well as ... corporate and collaborative partners, Regulatory Liaisons, vendor management and other cross-functional team members....a team-environment and can provide feedback for process or project needs. + Excellent written and oral communication skills.… more
- Novo Nordisk (Lexington, MA)
- …Are you ready to make a difference The Position The Clinical Pharmacology Specialist can be accountable for the Clinical pharmacology strategy for phase 1-4 in ... and administration strategy, including dose setting and dosing regimen for project (s), Scientific and pharmacology aspects of trials in the clinical development… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …across the company, including Manufacturing, Process Sciences (PS), Quality Control (QC), CMC Regulatory Sciences, and Quality Assurance (QA) to provide ... Regeneron is currently looking for an Analytical Specialist for our QC Analytical Sciences Extractables and...projects and deliverables to support pre and post marketing regulatory commitment deadlines, and development of new projects and… more
- Astellas Pharma (Sanford, NC)
- …support both internal and external audits; Assists in the preparation and review of CMC regulatory submissions + Collect and report, track and maintain metrics ... please visit our website: www.astellasgenetherapies.com. **The Role:** The Senior Specialist , QC Systems Support will be responsible for defining requirements,… more
- Eurofins (Columbia, MO)
- …GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC laboratory services for the world's largest pharmaceutical and biopharmaceutical ... Eurofins BPT-Columbia is looking for a Quality Engineering Validation Specialist to join our Quality Systems team located in...Must rapidly become current and remain expert on the regulatory requirements pertaining to computer systems used in the… more
- Verista (Boston, MA)
- …in a pharmaceutical setting: + Cell and gene therapy cGMP's and associated CMC regulatory considerations + Aseptic processing + Experience successfully leading ... technical advice for fill finish related program decisions + Provides project support involving technical transfers, engineering projects and similar activities +… more
- Merck (North Wales, PA)
- …to the information that they need. + Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common ... **Job Description** The drug development Project Manager is part of Global Project...strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... in accordance with Rush policies and procedures. **Responsibilities:** * Appropriately manage project billing by ensuring costs are correctly billed and invoices are… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include: Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... budget overlay in a timely manner. * Review clinical trial protocols and related regulatory documents in order to prepare a billing plan for all medical procedures… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... timely manner. * Review clinical trial protocols and related regulatory documents to prepare a billing plan for all...medical procedures and services required in a clinical research project . * Review clinical research protocols and determine which… more