Job Location: Remote
Duration: 6 months
Duties
- Reviews communications about company products for compliance with federal drug advertising regulations and consistency with approved labeling.
- Requires knowledge of regulated drug promotion, very basic statistics, ability to read and understand product labeling and scientific references.
- This position will work under the supervision of more senior Regulatory Reviewers and attend multi-disciplinary meetings to reveiw promotional claims and approve materials.
- Reviewer will be responsible for reviewing and submitting FDA 2253 forms.
Skills
- PC literacy required; proficient use of technology including MS Office skills (Outlook, Word, Excel, PowerPoint, MS project and Internet resources is expected).
- Strong knowledge and application of FDA regulations specific to Advertising and Promotion.
- Must be able to work independently with minimal supervision.
- Excellent organizational, interpersonal and communication skills (oral and written).
Education
- Bachelors degree required, preferably in a science-based field.