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Medical Writer

Company: Beacon Hill Staffing Group - Pharma
Location: High Point
Posted on: September 6, 2018

Job Description:

Responsible for authoring, organizing and updating the scientific and technical portions of FDA Premarket Tobacco Applications such as Substantial Equivalence and Exemption Requests, Modified Risk Tobacco Product Applications, and responses to FDA requests for information. Translates scientific data into meaningful narratives on behalf of the Company in order to meet the right regulatory requirements and standards. Proactive identification of the Company needs and priorities, and the utilization of computer databases and other relevant methodologies. Commitment to project management timelines in order to ensure the Company has the quality and time to approve any submissions in a rigorous manner. Interacting routinely with various internal groups and external consultants (e.g. Product Science, Corporate Quality, Product Development, Operations, Marketing and Legal) to ensure all regulatory submissions and responses to the FDA requests for information are properly organized, appropriate and scientifically accurate and completed in a timely manner. Basic requirement: 2 years regulatory writing experience, Science degree

Keywords: Beacon Hill Staffing Group - Pharma, High Point , Medical Writer, Advertising , High Point, North Carolina

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