- Piper Companies (Philadelphia, PA)
- Piper Companies is currently looking for an experienced Sr. Regulatory Specialist (IND Submissions) in Philadelphia, Pennsylvania (PA) to work for an innovative ... and growing biologic oncology pharmaceutical company. The Sr. Regulatory Specialist will play an integral part...review workflows including SharePoint and Master Control responsibilities for regulatory affairs and CMC regulatory ..… more
- ConvaTec (Lexington, MA)
- …working relationships within RA group as well as internal/external customers. ** Regulatory Affairs Specialist work includes:** Direct submission development of ... to expedite approval of pending registration and answer questions;** Serve as regulatory liaison on project team throughout the product lifecycle;** Participate… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …and clinicians in hematology, immunology, neurology, and transfusion medicine. The **Sr. Specialist for Regulatory Affair** **s** is responsible for ... including submission, operational and compliance for US-licensed products and additional project /s assigned. Responsibilities include: + As the US Product Owner… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Provide proactive support and technical assistance during preparation and review of regulatory documents + As assigned, participate in project teams + Assist ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Complete internet searches + Proactively manage the scope of project responsibilities, identify and compose draft correspondence relevant to… 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 a Materials Sciences Specialist for Extractables and Leachables (E&L) in the...projects and deliverables to support pre and post marketing regulatory commitment deadlines, and development of new projects 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 ... 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
- 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
