Director - Regulatory Affairs Advertising & Promotion
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Director Regulatory Affairs, US Advertising and Promotion is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan. He/she will contribute to strategic planning for the department (and departmental achievement of initiatives to meet goals and plan), manage assigned projects, and develop individual and team performance within the assigned franchise. He/she will also network and benchmark outside of AbbVie to provide for best practices and processes.
Responsibilities
Advise cross-functional teams on content and message consistency and best practices regarding planning and execution of marketing strategies.
Assure that cross-functional advertising and promotion review teams are operating according to approved company processes and procedures.
Be responsible for the training of regulatory staff, as required.
Provide regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies.
Conduct review and approval of professional and direct to consumer advertising and promotion and providing comments to review teams.
Effectively lead and establish strong working relationships with cross-functional review teams, both internal and with co-promotional partners. Serves as leader of cross-functional promotion review team meetings.
Possess strong working knowledge of DDMAC guidance and applies understanding to business situations.
Based upon sound regulatory knowledge, make and execute challenging decisions, understanding when a decision should be elevated to upper management for further consideration.
Advise Regulatory Operations group regarding special requirements for FDA 2253 submissions.
Work closely with RA labeling group regarding package insert changes to assure that promotional PI and important safety information are updated as appropriate.
Qualifications
As a qualified candidate, you must posses a Bachelor's Degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology). A Master’s, Ph.D. or Pharm D is preferred.
You should also posses 10 years of pharmaceutical experience, with 5 years direct advertising and promotion review experience. While 5 years advertising and promotion regulatory experience is preferred, medical/scientific affairs experience may be considered.
Having already worked directly in this area, you must have a solid understanding of regulatory advertising and promotion regulations.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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Director - Regulatory Affairs Advertising & Promotion
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Director Regulatory Affairs, US Advertising and Promotion is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan. He/she will contribute to strategic planning for the department (and departmental achievement of initiatives to meet goals and plan), manage assigned projects, and develop individual and team performance within the assigned franchise. He/she will also network and benchmark outside of AbbVie to provide for best practices and processes.
Responsibilities
Advise cross-functional teams on content and message consistency and best practices regarding planning and execution of marketing strategies.
Assure that cross-functional advertising and promotion review teams are operating according to approved company processes and procedures.
Be responsible for the training of regulatory staff, as required.
Provide regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies.
Conduct review and approval of professional and direct to consumer advertising and promotion and providing comments to review teams.
Effectively lead and establish strong working relationships with cross-functional review teams, both internal and with co-promotional partners. Serves as leader of cross-functional promotion review team meetings.
Possess strong working knowledge of DDMAC guidance and applies understanding to business situations.
Based upon sound regulatory knowledge, make and execute challenging decisions, understanding when a decision should be elevated to upper management for further consideration.
Advise Regulatory Operations group regarding special requirements for FDA 2253 submissions.
Work closely with RA labeling group regarding package insert changes to assure that promotional PI and important safety information are updated as appropriate.
Qualifications
As a qualified candidate, you must posses a Bachelor's Degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology). A Master’s, Ph.D. or Pharm D is preferred.
You should also posses 10 years of pharmaceutical experience, with 5 years direct advertising and promotion review experience. While 5 years advertising and promotion regulatory experience is preferred, medical/scientific affairs experience may be considered.
Having already worked directly in this area, you must have a solid understanding of regulatory advertising and promotion regulations.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html