Scientific Writer

Advanced Personnel Resources is seeking experienced Scientific Writers for a new opportunity with our client here in the Triad area. The Scientific Writer will provide support to the Regulatory Science Team by reviewing scientific data and narratives to ensure all federal and state requirements are being met. The Scientific Writer will further be responsible for authoring, organizing, and updating all regulatory submissions to federal and state entities, and will regularly review submission reports for quality control.

Job Duties:

• Responsible for the Quality Control of all regulatory submissions and developing the timelines and processes for the submissions.
• Provides support through quality control for the primary regulatory ingredient reporting and other scientific data required for regulatory reporting through the proactive identification of the Company needs and priorities, and the utilization of computer databases and other relevant methodologies.
• Supports Regulatory Science Team through processes surrounding the regulatory submissions and approvals with any entity outside of RSA, including function (Product Science) or legal and regulatory consultants by reviewing regulatory products.
• Ensures providers of scientific data or narratives on behalf of the Company are provided the right requirements to meet standards and understanding the project management timelines in order to ensure the Company has the quality and time to approve any submissions in a rigorous manner.
• Interacts routinely with various internal groups and external consultants (e.g. Corporate Quality, Product Development, Operations, Marketing, and Legal) to ensure all regulatory submissions and responses to the requests for information are properly organized, appropriate, and scientifically accurate and completed in a timely manner.
• Reviews submissions and other reports of relevant information to the proper authoritative areas and prepares relevant submissions to regulatory agencies by maintaining and utilizing informational databases.
• Adheres to general standards to promote a cooperative working environment by utilizing communication skills, interpersonal relationships and team building.

Qualifications:

• Bachelor's in Biology or Chemistry is preferred but not required
• 5+ years of Regulatory writing experience
• Previous knowledge of Quality Assurance and Auditing is preferred
• Willingness to commit to a 1+ year contract assignment