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Global Labeling Manager  – Consultant – NJ $70-$75/hr Description:   Duties: Facilitate and Lead the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS) and Country Product Information (CPI) and CPI components for assigned products either globally as a Global Labeling Lead or regional/local as a Regional Labeling Lead. Functioning independently as …

Exciting Contract Opportunity w/global Pharma in NJ $90/hr+ Work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents. Responsibilities include preparation of regulatory documents on behalf of Company in accordance with the ICH guidelines, international regulations,  standards and processes, …

Global Labeling Manager – NJ Contractor (1-3 years) Hourly Rate: $60-$65/hr   Duties: Facilitate and lead the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS) and Country Product Information (CPI) and CPI components for assigned products either globally as a Global Labeling Lead or regional/local as a Regional Labeling Lead. Functioning …

Project Coordinator, Corporate Ethics and Compliance – NJ 1Year Contract – $30-$35hr DESCRIPTION: The Project Coordinator, Corporate Ethics and Compliance, will report to the Executive Director, Corporate Ethics and Compliance (CECD), and assist with the development and implementation of programs supporting the Corporate Ethics and Compliance Program. General responsibilities include: Initiation and review of healthcare sanction …

Director Quality Assurance & Regulatory Affairs Based in NJ Outstanding leadership opportunity with a full-service outsourced manufacturer of Class I, II and III electro-mechanical capital equipment to the medical device industry. Founded in 1999, the Company has a strong track record of growth and an outstanding reputation with its customers based upon its leading technical …

Sr. Regulatory Affairs Associate – Full-Time (2 open)      Based in New York City & San Francisco   Outstanding growth opportunity with a world-class global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. They have a  unique expertise in understanding the interaction of light and human skin, …

Director Quality Assurance & Regulatory Affairs Based in NJ Outstanding leadership opportunity with a full-service outsourced manufacturer of Class I, II and III electro-mechanical capital equipment to the medical device industry. Founded in 1999, the Company has a strong track record of growth and an outstanding reputation with its customers based upon its leading technical …

Duties: Publishing Specialist will be part of the Regulatory Operations Publishing Group and to ensure that dossier is prepared ready to submit to the FDA and other agencies. This includes, Publishing(Bookmarking and Hyperlinking) and Peer Reviewing different types of document like (eg Clinical Study Report, Annual Report, Protocol, Amendments, PSUR, DMF, IMPD, CRFs and eCRF …

Quality Control Specialist will provide support to the Regulatory Affairs for QC of Medical Writing and other documents as needed. Responsibilities will include QC of all documents written in Medical Writing to include protocols, protocol amendments, investigator brochures, clinical study reports, and regulatory documentation. The QC Specialist is responsible for performing accurate, precise proof- reading …

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Sr. Publishing Specialist 1 yr Contract – NJ   Duties: The Senior Publishing Specialist will be part of the Regulatory Operations Publishing Group and to ensure that dossier is prepared ready to submit to the FDA and other agencies. This includes: Publishing(Bookmarking and Hyperlinking) and Peer Reviewing different types of document like (eg Clinical Study …