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USA-Project Manager III (Professional)

Job Description

Regulatory Advertising and Promotion Reviewer #21-03745
Cambridge, MA
**Fully Remote Opportunity

Job Description:
  • Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
  • Work directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB submission.
  • Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials
  • Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines.
  • Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
  • Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.
  • Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
  • Serve as FDA liaison for matters related to the advertising and promotion of assigned products.
Job Requirements:
  • 5+ years experience in advertising/promotion review
  • Experience as FDA liaison for issues relating to promotional material
  • Ability to review material for compliance with federal regulations and guidelines and corporate policy with little oversight
  • Ability to learn new products and quickly
  • Demonstrated ability to work collaboratively with legal, medical, and commercial
  • *Preferred, but not required: experience with diabetes/metabolism products.
  • This role will be fully remote

Job Requirements

 

Job Snapshot

Location US-MA-Cambridge
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-MA-Cambridge
Soma Emmadi
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Snapshot
Ascent
Company:
US-MA-Cambridge
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific
Store Type:

Job Description

Regulatory Advertising and Promotion Reviewer #21-03745
Cambridge, MA
**Fully Remote Opportunity

Job Description:
  • Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
  • Work directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB submission.
  • Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials
  • Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines.
  • Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
  • Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.
  • Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
  • Serve as FDA liaison for matters related to the advertising and promotion of assigned products.
Job Requirements:
  • 5+ years experience in advertising/promotion review
  • Experience as FDA liaison for issues relating to promotional material
  • Ability to review material for compliance with federal regulations and guidelines and corporate policy with little oversight
  • Ability to learn new products and quickly
  • Demonstrated ability to work collaboratively with legal, medical, and commercial
  • *Preferred, but not required: experience with diabetes/metabolism products.
  • This role will be fully remote

Job Requirements

 
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USA-Project Manager III (Professional) Apply now