Maxis Clinical Sciences Hiring for Regulatory Reviewer (Remote) at Ridgefield, CT Full Time

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 reveiw promotional claims and approve materials. Reveiwer 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.

Required

• ADVERTISING PROMOTION
• FDA
• REGULATORY AFFAIRS
• PHARMACY

Company Description

Maxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.

Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and ing services, data anonymization services, RWD aggregation and curation services etc.

Maxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience. Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and ing services, data anonymization services, RWD aggregation and curation services etc.