- US Tech Solutions, Inc. (Atlanta, GA)
- …Develop and maintain document management systems. Provide technical writing support for regulatory documents. Collaborate with project leaders and subject matter ... Job Title: Documentation Specialist II Location: Remote Duration: 12 months contractwith...provide product and process understanding, as well as analytical CMC program management. Responsibilities: Generate document templates for Analytical… 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
- Bausch + Lomb (Bridgewater, NJ)
- …advancement of eye health in the future. **Objectives/Purpose of Job:** + The Regulatory Affairs Senior Specialist handles US regulatory development aspects ... for Over-the-Counter (OTC) or cosmetic products, as assigned. + Provides Regulatory guidance to support marketed OTC monograph/NDA or cosmetic products. + Manages… 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
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Specialist leverages their regulatory ... as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… 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
- Bausch Health (Bridgewater, NJ)
- …of improving people's lives with our health care products. The Quality Specialist provides support for the business' product development portfolio and ensures ... to Quality-by-Design principles as well as compliance with relevant regulatory requirements and corporate standards. Experience: + Partner with cross-functional… more
- US Tech Solutions (CA)
- …and maintain **document management systems.** + Provide technical writing support for ** regulatory documents.** + Collaborate with project leaders and **subject ... + Searching for a highly motivated individual to fill the Documentation Specialist role in the Analytical Development Department. + The Analytical Development… more
- Actalent (Foster City, CA)
- …variety of activities to ensure compliance with applicable quality objectives and regulatory requirements * Serves as QA Lead for clinical and commercial projects. ... data for in-process and finished products. * Reviews method validation-related data in CMC sections of NDA / global filings. * Responsible for maintaining current… 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
- Magellan Health Services (Boise, ID)
- …design principles and methodologies. + Collaborates with Corporate Operations, IT Project Management, Care Management Center ( CMC ) Learning and Performance ... for new hire training. + Serves as subject matter expert (SME) for CMC Learning Leaders/ Specialist in reference to call center policies/procedures content as… 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
