AbbVie

Manager/Senior Manager, Regulatory Affairs Advertising & Promotional Materials

Employer
AbbVie
Location
Virtual Office, United States
Posted
Aug 29, 2020
Ref
2004840
Required Education
Masters Degree/MBA
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

  • GENERAL POSITION SUMMARY/PURPOSE:
    This staff is responsible for regulatory review and approval of commercial materials for respective products/indications. Contributes to strategic regulatory advice on advertising and promotion materials and activities for assigned products in accordance with business goals and objectives, FDA regulations/guidelines, PhRMA guidelines and company policy. Influences teams for assigned products and projects to implement compliant product labeling and communications. Facilitates the smooth operation of the company's Materials Approval and Review Committees (MARC) process for assigned indications. The MARC scope includes Promotional, Scientific, and Corporate communications. Serves as PRC chair when necessary. All relevant products or candidates are in the hematology/oncology therapeutic space.

    KEY ACCOUNTABILITIES/CORE JOB RESPONSIBILITIES:
  • Conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with FDA approved labeling and delivers consistent, well-supported, and clear guidance
  • Evaluates materials to ensure compliance with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act
  • Develops and guides implementation strategies for promotional activities
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas/disease states
  • Effectively presents pertinent information to appropriate cross-functional groups
  • Effectively delivers difficult messages to commercial organization while maintaining collaborative environment
  • Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange
  • Advises Materials Approval and Review Committees (MARC) Operations Management (MOM) and/or Regulatory Operations group regarding requirements for FDA 2253 submissions
  • Ensures departmental training and compliance with established regulations, guidance's, promotional guidelines, and SOPs related to advertising and promotion regulations for self and direct reports, if applicable.
  • Manages and assist in the development, training and mentoring of staff members


Qualifications

Manager:
  • Advanced degree required, advance allied health degree such as MS of nursing, PharmD, MD, NP, PhD. Prior experience in clinical development or medical affairs very beneficial.
  • Minimum of 3-5+ years of relevant Regulatory Affairs, Advertising and Promotional Materials experience in the pharmaceutical/biotechnology industry, ideally prior experience with Orphan Drugs and Subpart H approval.

Sr. manager:

  • Bachelor's degree (or equivalent)
  • 6-8 years of pharmaceutical industry experience, including 2-4 years in regulatory affairs Advertising and Promotion or similar experience
  • Deep and broad knowledge of FDA regulations and guidelines
  • Excellent verbal and written skills. Effectively communicates difficult and complex issues in a way that accurately and persuasively identifies the issues to be resolved to internal and external stakeholders
  • Strong interpersonal skills with the ability to influence within a cross-functional team or partnership environment in a positive, effective, and professional manner
  • Skilled in conflict resolution and negotiation. Fosters open communication. Listens and facilitates discussion and resolution. Able to make ethical and compliant decisions
  • Strong organizational and prioritization skills


PREFERRED:

  • RAC , PharmD or Lawyer desirable
  • Experience in commercial regulatory and advertising promotion preferred.


Significant Work Activities
N/A
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.