What are the responsibilities and job description for the Regulatory Reviewer position at System One?
Job Title: Regulatory Reviewer
Location: Remote
Duration: 6 Months
Pay Range: $40-44/hr
Type: Contract
Overview:
Joule is partnering with a client that is seeking a candidate with prior FDA reviewing and submission experience within advertising and promotions. Some of the top skills that candidate must have to be successful in this role include having experience in: FDA, Pharmacy, Advertising promotion, regulatory affairs. Submit you application today for immediate consideration!
Responsibilities
Requirements
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Location: Remote
Duration: 6 Months
Pay Range: $40-44/hr
Type: Contract
Overview:
Joule is partnering with a client that is seeking a candidate with prior FDA reviewing and submission experience within advertising and promotions. Some of the top skills that candidate must have to be successful in this role include having experience in: FDA, Pharmacy, Advertising promotion, regulatory affairs. Submit you application today for immediate consideration!
Responsibilities
- Reviews communications about company products for compliance with federal drug advertising regulations and consistency with approved labeling.
- Requires a 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 review promotional claims and approve materials.
- Reviewer will be responsible for reviewing and submitting FDA 2253 forms.
Requirements
- Bachelors degree required, preferably in a science-based field.
- 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).
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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