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Sr Manager, Regulatory Advertising and Promotional Review (974692)

In New Jersey / United States

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Sr Manager, Regulatory Advertising and Promotional Review (974692)   

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JOB TITLE:

Sr Manager, Regulatory Advertising and Promotional Review (974692)

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Franklin Lakes New Jersey / United States

JOB DESCRIPTION:

Responsibilities:

  • Review promotional materials and ensure that they are ( i) accurate, truthful and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures.
  • Act as primary OPDP agency Liaison; Maintain and foster relationships with agency contacts in OPDP on an expert peer to peer basis.
  • Perform Regulatory review of internal and external business communications as requested.
  • Enhance collaboration across a matrixed organization while developing and maintaining constructive relationships.
  • Provide support for potential new product launches, including promotional review of launch materials, implementation of OPDP advisory comment submissions, and interactions with the Agency.
  • Monitor and share information on regulatory developments in Advertising and promotion.
  • Effectively communicate regulatory issues and concerns to senior governance groups including Marketing, Legal and Medical, as necessary.
  • Provide guidance for team on overall benefit/risk assessments of promotional activities and strategies.
  • Assist with the development of policy and internal guidance on Advertising and promotion activities.
  • Ensure business compliance and implementation of and adherence to Regulatory standards.
  • Work independently and recognize when issues need to be elevated to Management.
  • Demonstrate a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
  • Strong negotiation and communication skills.

Requirements:

  • BS or equivalent is required. Science degree/advanced degree is preferred.
  • 5 + years prior experience as a regulatory reviewer of US Advertising & Promotion.
  • 8 + years of overall pharmaceutical experience, ideally including exposure to general Regulatory Strategy and Product lifecycle management.
  • Experience interacting with FDA including OPDP.
  • Demonstrated experience of effective delivery in complex matrix environment.

Position Details

POSTED:

Jun 23, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204865164073795

LOCATION:

New Jersey / United States

CITY:

Franklin Lakes

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Sr Manager, Regulatory Advertising and Promotional Review (974692)    Apply

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Responsibilities:

  • Review promotional materials and ensure that they are ( i) accurate, truthful and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures.
  • Act as primary OPDP agency Liaison; Maintain and foster relationships with agency contacts in OPDP on an expert peer to peer basis.
  • Perform Regulatory review of internal and external business communications as requested.
  • Enhance collaboration across a matrixed organization while developing and maintaining constructive relationships.
  • Provide support for potential new product launches, including promotional review of launch materials, implementation of OPDP advisory comment submissions, and interactions with the Agency.
  • Monitor and share information on regulatory developments in Advertising and promotion.
  • Effectively communicate regulatory issues and concerns to senior governance groups including Marketing, Legal and Medical, as necessary.
  • Provide guidance for team on overall benefit/risk assessments of promotional activities and strategies.
  • Assist with the development of policy and internal guidance on Advertising and promotion activities.
  • Ensure business compliance and implementation of and adherence to Regulatory standards.
  • Work independently and recognize when issues need to be elevated to Management.
  • Demonstrate a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
  • Strong negotiation and communication skills.

Requirements:

  • BS or equivalent is required. Science degree/advanced degree is preferred.
  • 5 + years prior experience as a regulatory reviewer of US Advertising & Promotion.
  • 8 + years of overall pharmaceutical experience, ideally including exposure to general Regulatory Strategy and Product lifecycle management.
  • Experience interacting with FDA including OPDP.
  • Demonstrated experience of effective delivery in complex matrix environment.


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