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Sr. Manager, Regulatory Advertising and Promotional Review - REMOTE opportunity - PHARMA EXP. MANDATORY

In Connecticut / United States

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Sr. Manager, Regulatory Advertising and Promotional Review - REMOTE opportunity - PHARMA EXP. MANDATORY   

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JOB TITLE:

Sr. Manager, Regulatory Advertising and Promotional Review - REMOTE opportunity - PHARMA EXP. MANDATORY

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Stamford Connecticut / United States

JOB DESCRIPTION:

Job Title: Sr. Manager, Regulatory Advertising and Promotional Review

Location: Stamford, Connecticut but can work REMOTE

Duration: 3 months contract-to-hire to fulltime role

Job Summary:

This role is on the US Regulatory Labeling, Advertising and Communication team, and will provide strategic support to the review of Advertising and Promotion materials in order to meet US Commercial objectives while ensuring the necessary level of regulatory compliance including meeting Office of Prescription Drug Promotion (OPDP) directives. The materials can include advertising or promotional materials, slide presentations for corporate communications, training materials for salesforce, press releases and other outward facing materials. Responsible for evaluating all advertising/promotional regulatory issues; developing and reviewing regulatory strategies for promotion of marketed and pipeline products; and serves as the lead Regulatory Affairs representative on the MRL committee.

Primary 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.

Additional Knowledge, Skills and Abilities:

  • 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.

Education and Experience Requirements:

  • BS or equivalent is required. Science degree/advanced degree is preferred.
  • Five + years prior experience as a regulatory reviewer of US Advertising & Promotion.
  • Eight + 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:

S16204864105562262

LOCATION:

Connecticut / United States

CITY:

Stamford

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 - REMOTE opportunity - PHARMA EXP. MANDATORY    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Job Title: Sr. Manager, Regulatory Advertising and Promotional Review

Location: Stamford, Connecticut but can work REMOTE

Duration: 3 months contract-to-hire to fulltime role

Job Summary:

This role is on the US Regulatory Labeling, Advertising and Communication team, and will provide strategic support to the review of Advertising and Promotion materials in order to meet US Commercial objectives while ensuring the necessary level of regulatory compliance including meeting Office of Prescription Drug Promotion (OPDP) directives. The materials can include advertising or promotional materials, slide presentations for corporate communications, training materials for salesforce, press releases and other outward facing materials. Responsible for evaluating all advertising/promotional regulatory issues; developing and reviewing regulatory strategies for promotion of marketed and pipeline products; and serves as the lead Regulatory Affairs representative on the MRL committee.

Primary 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.

Additional Knowledge, Skills and Abilities:

  • 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.

Education and Experience Requirements:

  • BS or equivalent is required. Science degree/advanced degree is preferred.
  • Five + years prior experience as a regulatory reviewer of US Advertising & Promotion.
  • Eight + 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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