- Novo Nordisk Inc. (Plainsboro, NJ)
- …Provide proactive support and technical assistance during preparation and review of regulatory documents As assigned, participate in project teams Assist with ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Merck & Co. (North Wales, PA)
- …people to the information that they need.Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common ... Job DescriptionThe 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
- 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
- Merck (West Point, PA)
- …Technical Operations, Operations, Quality Operations, Supplier Quality Management, Planning, Regulatory - CMC , Global Technical Operations and Supply Chain. + ... a multi-product vaccine manufacturing facility located in West Point, PA. The Specialist , Technical Operations Engineer in this position is responsible for managing… 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