Director, Regulatory Affairs Advertising & Promotion - Immunology
Allergan, Mettawa, Illinois, United States
Overview
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. The Director will also network and benchmark outside of AbbVie to provide for best practices and processes.
Responsibilities
Advisecross-functional teams on content and message consistency and best practices regarding planning and execution of marketing strategies.
Assurethat 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.
Conductreview 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, makeand executechallenging decisions,understandingwhen a decision should be elevated to upper management for further consideration.
AdviseRegulatory Operations group regarding special requirements for FDA 2253 submissions.
Workclosely with RA labeling group regarding package insert changes to assure that promotional PI and important safety information are updated as appropriate.
This role will work a hybrid work schedule (3 days in office) from our Mettawa, IL AbbVie headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications As a qualified candidate, you must possess a bachelor’s degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).
AMaster’s, Ph.D. or Pharm D is preferred .
You should also possess
10 years of pharmaceutical experience with a bachelor degree or 8+ years with a Pharm D or Ph.D. , with
5 years’ direct advertising and promotion review experience . While 5 years of advertising and promotion regulatory experience is preferred, medical/scientific affairs experience may be considered.
Given your direct experience in this field,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 orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
This job is eligible to participate in our short-term incentiveprograms.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable. The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable 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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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. The Director will also network and benchmark outside of AbbVie to provide for best practices and processes.
Responsibilities
Advisecross-functional teams on content and message consistency and best practices regarding planning and execution of marketing strategies.
Assurethat 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.
Conductreview 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, makeand executechallenging decisions,understandingwhen a decision should be elevated to upper management for further consideration.
AdviseRegulatory Operations group regarding special requirements for FDA 2253 submissions.
Workclosely with RA labeling group regarding package insert changes to assure that promotional PI and important safety information are updated as appropriate.
This role will work a hybrid work schedule (3 days in office) from our Mettawa, IL AbbVie headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications As a qualified candidate, you must possess a bachelor’s degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).
AMaster’s, Ph.D. or Pharm D is preferred .
You should also possess
10 years of pharmaceutical experience with a bachelor degree or 8+ years with a Pharm D or Ph.D. , with
5 years’ direct advertising and promotion review experience . While 5 years of advertising and promotion regulatory experience is preferred, medical/scientific affairs experience may be considered.
Given your direct experience in this field,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 orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
This job is eligible to participate in our short-term incentiveprograms.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable. The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable 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
#J-18808-Ljbffr