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USA-Project Manager III (Professional)

Job Description

Project Manager III #21-03015
Bridgewater, NJ
**Remote
 
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.
• Will be responsible for certifying material compliance to the FDA on behalf of client, and as such it is imperative, they have adequate experience and background to perform that role.
• Serve as FDA liaison for matters related to the advertising and promotion of assigned products
 
Job Requirements:
• 7 years in Regulatory ad/promo experience.
• Must have Quality experience
• Seeking candidates that require minimal oversight.
**Must have advertising and promotional review experience.

Job Requirements

 

Job Snapshot

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

Job Description

Project Manager III #21-03015
Bridgewater, NJ
**Remote
 
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.
• Will be responsible for certifying material compliance to the FDA on behalf of client, and as such it is imperative, they have adequate experience and background to perform that role.
• Serve as FDA liaison for matters related to the advertising and promotion of assigned products
 
Job Requirements:
• 7 years in Regulatory ad/promo experience.
• Must have Quality experience
• Seeking candidates that require minimal oversight.
**Must have advertising and promotional review experience.

Job Requirements

 
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USA-Project Manager III (Professional) Apply now