- 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
- Merck (North Wales, PA)
- …the Research & Development organization at our company. **Position Description/Summary** The Senior Specialist , Project Manager is a core member of Early Drug ... strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive… 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
- Merck (Rahway, NJ)
- …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 ... 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