1+ months

Associate Director Regulatory Affairs, Advertising & Promotion

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    115480103
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

Position Summary:

The Regulatory Affairs Advertising and Promotion Associate Director is responsible for reviewing internal and external communications including advertising and promotional activities as well as facilitation of labeling development, maintenance and distribution for all ACADIA products. Coordinates the development and implementation of regulatory strategies for promotion and advertising plans, and provides Regulatory leadership and guidance in the Medical, Legal and Regulatory Review process to support approval and dissemination of marketed product and disease state promotional material.

This role will work closely with the Head for Regulatory Advertising and Promotion and other Sr. Regulatory Affairs Dept. Staff with the development and implementation of regulatory strategies for promotion and advertising plans, and projects concerning the construct of proposed labeling for regulatory submissions according to product data and ACADIA objectives.

Primary Duties & Responsibilities:

  • Reviews promotional/non-promotional materials, including training, for completeness and compliance with FDA regulations, guidance documents, and company policy
  • Represents the regulatory perspective at and leading the Medical, Legal, and Regulatory Review process to support review and approval of appropriate materials
  • Assumes a leadership role in advising teams on the regulatory impact of new promotional messages or concepts, updates to label, and provides regulatory guidance on corporate communications, medical affairs activities, and appropriate pre-approval activities with some managerial oversight
  • Participates in training of sales and marketing personnel on advertising and promotional materials
  • Update and advise sales and marketing personnel on changes in regulations, policies, and enforcement which may impact the ACADIAs promotional activities
  • Leads the FDA-OPDP 2253 submission process for all ACAIDA products
  • Assists in the development and maintenance of labeling

Education/Experience/Skills:

Science or healthcare related degree preferred, including BS, MS, MPH, PharmD. Minimum of 8 years of experience in the pharmaceutical or related industry; a minimum of 4 years experience with regulatory review of advertising and promotional materials for prescription drug and/or biologic products. This includes:

  • Experience communicating and negotiating with different levels within the organization and performing risk assessment
  • Demonstrated experience developing, executing, and influencing organizational direction as it pertains to compliant advertising and promotion materials or activities
  • Experience in organizational management, including matrix management of senior professionals and higher-level project teams

Must possess:

  • Ability to interpret and implement FDA regulations as it pertains to Advertising and Promotion of Pharmaceutical products.
  • Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
  • Ability to work in a cross-functional team environment and a flexible team-oriented perspective with minimal direction from a senior Regulatory Affairs professional.
  • Ability to problem solve and effectively manage or resolve conflicts.
  • Excellent verbal and written organizational and communication skills, and experience influencing and communicating Regulatory Advertising and Promotional issues
  • Ability to negotiate with business partners or management regarding Regulatory Advertising and Promotion matters of significance to the organization.
  • Ability to effectively present information to senior regulatory management, other departments or external groups.
  • Ability to adapt to changing priorities and prioritize work effectively.

Scope:

  • Provides proactive guidance to cross-functional team members based on technical and regulatory knowledge towards development of Regulatory Advertising and Promotion materials and strategies.
  • Identify, assess, and effectively manage regulatory risks associated with advertising and promotional materials or activities for assigned products.
  • Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.
  • Effectively participates in key meetings to provide Regulatory Advertising and Promotion guidance to help support ACADIAs business objectives.
  • Assists Sr. Regulatory Affairs Staff in the AdPromo and labeling compliance review on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objective

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.


PI115480103

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p><strong><u>Position Summary:</u></strong></p> <p>The Regulatory Affairs Advertising and Promotion Associate Director is responsible for reviewing internal and external communications including advertising and promotional activities as well as facilitation of labeling development, maintenance and distribution for all ACADIA products. Coordinates the development and implementation of regulatory strategies for promotion and advertising plans, and provides Regulatory leadership and guidance in the Medical, Legal and Regulatory Review process to support approval and dissemination of marketed product and disease state promotional material. </p> <p>This role will work closely with the Head for Regulatory Advertising and Promotion and other Sr. Regulatory Affairs Dept. Staff with the development and implementation of regulatory strategies for promotion and advertising plans, and projects concerning the construct of proposed labeling for regulatory submissions according to product data and ACADIA objectives.</p> <p><strong><u>Primary Duties & Responsibilities:</u></strong></p> <ul> <li>Reviews promotional/non-promotional materials, including training, for completeness and compliance with FDA regulations, guidance documents, and company policy</li> <li>Represents the regulatory perspective at and leading the Medical, Legal, and Regulatory Review process to support review and approval of appropriate materials</li> <li>Assumes a leadership role in advising teams on the regulatory impact of new promotional messages or concepts, updates to label, and provides regulatory guidance on corporate communications, medical affairs activities, and appropriate pre-approval activities with some managerial oversight</li> <li>Participates in training of sales and marketing personnel on advertising and promotional materials</li> <li>Update and advise sales and marketing personnel on changes in regulations, policies, and enforcement which may impact the ACADIAs promotional activities</li> <li>Leads the FDA-OPDP 2253 submission process for all ACAIDA products</li> <li>Assists in the development and maintenance of labeling</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <p>Science or healthcare related degree preferred, including BS, MS, MPH, PharmD. Minimum of 8 years of experience in the pharmaceutical or related industry; a minimum of 4 years experience with regulatory review of advertising and promotional materials for prescription drug and/or biologic products. This includes:</p> <ul> <li>Experience communicating and negotiating with different levels within the organization and performing risk assessment</li> <li>Demonstrated experience developing, executing, and influencing organizational direction as it pertains to compliant advertising and promotion materials or activities</li> <li>Experience in organizational management, including matrix management of senior professionals and higher-level project teams</li> </ul> <p> Must possess:</p> <ul> <li>Ability to interpret and implement FDA regulations as it pertains to Advertising and Promotion of Pharmaceutical products.</li> <li>Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.</li> <li>Ability to work in a cross-functional team environment and a flexible team-oriented perspective with minimal direction from a senior Regulatory Affairs professional.</li> <li>Ability to problem solve and effectively manage or resolve conflicts.</li> <li>Excellent verbal and written organizational and communication skills, and experience influencing and communicating Regulatory Advertising and Promotional issues</li> <li>Ability to negotiate with business partners or management regarding Regulatory Advertising and Promotion matters of significance to the organization.</li> <li>Ability to effectively present information to senior regulatory management, other departments or external groups.</li> <li>Ability to adapt to changing priorities and prioritize work effectively.</li> </ul> <p><strong><u>Scope:</u></strong></p> <ul> <li>Provides proactive guidance to cross-functional team members based on technical and regulatory knowledge towards development of Regulatory Advertising and Promotion materials and strategies.</li> <li>Identify, assess, and effectively manage regulatory risks associated with advertising and promotional materials or activities for assigned products.</li> <li>Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.</li> <li>Effectively participates in key meetings to provide Regulatory Advertising and Promotion guidance to help support ACADIAs business objectives.</li> <li>Assists Sr. Regulatory Affairs Staff in the AdPromo and labeling compliance review on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objective</li> </ul> <p><strong><u>Physical Requirements:</u></strong></p> <p>While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.</p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/m6rz7ytbYPYYiKlqs4DL1"> <p>PI115480103</p>

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Posted: 2019-11-14 Expires: 2019-12-15

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Associate Director Regulatory Affairs, Advertising & Promotion

ACADIA Pharmaceuticals
San Diego, CA 92101

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