- 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 ... surveillance and US regulatory licensing. **Responsibilities** + Proactively communicate CMC regulatory strategy, key issues and any other critical topics… 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. **In this role, a typical day might include:**… more
- West Pharmaceutical Services (Exton, PA)
- …a healthier environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist , Regulatory Project Management (RPM) role is ... Sr. Specialist , Regulatory Project Mgmt Requisition ID:...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… 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 ... is highly cross-functional and may involve some travel. Relationships Reports to the Senior Director, Clinical Pharmacology for the US East Coast Hub. Will interact… more
- Astellas Pharma (Sanford, NC)
- …For more information, please visit our website: www.astellasgenetherapies.com. **The Role:** The Senior Specialist , QC Systems Support will be responsible for ... external audits; Assists in the preparation and review of CMC regulatory submissions + Collect and report,...and training to junior colleagues **Quantitative Dimensions:** The QC Specialist IV, QC Systems Support will be responsible for… more
- Verista (Boston, MA)
- …in a pharmaceutical setting: + Cell and gene therapy cGMP's and associated CMC regulatory considerations + Aseptic processing + Experience successfully leading ... event investigations, Root Cause Analysis and CAPA + Experience with network-based applications such as Oracle, TrackWise + Master's degree with 2-3 years of relevant work experience, or Bachelor's degree in a scientific or allied health field with minimum 3-5… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …will be responsible for supporting the Process Sciences, Manufacturing, and CMC Regulatory Departments through compliance activities and documentation related ... Regeneron is looking for a Compliance Specialist to join our Process Sciences Change Management team. This is a non-lab based position. Regeneron has successfully… 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 ... integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas)… 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 ... federal and state compliance regulations. * Stays abreast of industry & regulatory changes impacting functional areas and revenue cycle. * Identifies potential… 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 ... overlay in a timely manner. * Review clinical trial protocols and related regulatory documents to prepare a billing plan for all medical procedures and services… more