For The Candidates

(919) Area Code

 Job Title:

              Durham/RTP Area

Promotional Review & Labeling Specialist

Job Description:

Reporting to the Director of Regulatory Affairs, the Regulatory Promotional Review and Labeling Specialist is responsible for the review and evaluation of promotional and advertising materials generated by Marketing, Communication, and Reimbursement groups by managing the system for approval of all product packaging and labeling to ensure regulatory compliance.
  The incumbent possesses knowledge of regulatory requirements applicable to promotional labeling gained through experience and is able to perform the essential duties and responsibilities with some direct supervision.
 

Required Skills:

• Review labeling and promotional materials to ensure compliance with FDA, FTC, international and other applicable requirements.
• Reviews statistical, clinical and non-clinical data and determines how these relate to proper support for medical, commercial or statistical
    claims in promotion of a given product. 
• Keep abreast of current information relating to the promotion of medical device, biologics, drugs, and combination products. 
• Coordinate and participate in review meetings for promotional materials.
• Provide guidance on compliance of materials under development.
• Coordinate activities related to new or revised product packaging labeling, including translations, layout, and printing of associated materials, such as the Instructions for Use.
   

Required Experience:

• BS/BA, in regulatory affairs, engineering, life sciences or other relevant area of study.  (other degrees may be considered)  Advance degree is preferred.
• A minimum 3 years of promotional material and labeling review experience required in the area of regulated medical  products (i.e. device, drugs, biologics). 
   
• Extensive knowledge of FDA, FTC and other applicable regulations is required.
• Must possess highly effective written and verbal communication skills.
• Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology and complex documents. 
  Ability to effectively present information to other employees, management and regulatory agencies.
• Must be detail-oriented and possess considerable organization skills.
• Ability to prioritize work and manage multiple projects under budget and time constraints.
• Ability to effectively partner with employees, management, department and cross-functional teams to meet performance objectives and to support mission and vision of the Company.

Years Of Experience:

 2+ to 5 Years

Level of Education:

 4 Year Degree