Associate Director, Regulatory Affairs Advertising & Promotion (Office-based)
BioSpace, Irvine, CA, United States
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Job Title Associate Director, Regulatory Affairs US Advertising and Promotion
The Associate Director is responsible for setting strategy and leading cross‑functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collecting and analyzing issues and trends that affect the business, identifying and acting upon cross‑organization or cross‑business opportunities and possessing and leveraging broad industry knowledge.
Responsibilities
Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross‑functional/multidisciplinary therapeutic teams and multidivisional initiatives.
Maintain and evaluate productivity metrics to project current and future business needs.
Align and maintain effective communication channels with key Medical, Marketing, Regulatory, Legal and Public Affairs counterparts. Identify areas of improvement in process/policy, develop recommendations/plan, and lead initiatives.
Assist in managing the departmental budget, identify and communicate budgetary needs to Operations and Finance, and project current and future expenditures and business needs.
Operate independently, with recognition of when to consult departmental senior concerning risks. In absence of Director, is responsible for day‑to‑day operations. Responsible for departmental initiatives, which have significant impact on both internal and external customers.
Encourage innovation and hold employees accountable for delivering on their goals; recognize, mentor, reward and recommend promotion for staff members based on their performance, results, and development.
Exhibit solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals. Possess and leverage broad industry knowledge.
Develop and implement complex processes and projects and deliver strategic presentations for senior management.
Identify areas of improvement in process, policy, develop recommendations/plan and lead initiatives.
This role will work a hybrid work schedule (3 days in office) from our AbbVie Mettawa, IL, Florham Park, NJ or Irvine, CA headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8‑hour day) is required.
Qualifications
Bachelor's degree plus 8+ years of relevant experience (e.g. applicable pharmaceutical/medical devices/biologics experience, pharmacy rotations, public health, etc.).
Advanced degree preferred: MS, MPH, MSN, PA, DNP, PhD, PharmD, JD, MD plus 6 years of relevant industry experience. Certification a plus.
Experience in US Regulatory Affairs Advertising and Promotion highly preferred.
Experience working in a complex and matrix environment.
Strong communication skills, both oral and written.
Experience developing and implementing successful global regulatory strategies.
Experience in management capacity preferred.
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.
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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Job Title Associate Director, Regulatory Affairs US Advertising and Promotion
The Associate Director is responsible for setting strategy and leading cross‑functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collecting and analyzing issues and trends that affect the business, identifying and acting upon cross‑organization or cross‑business opportunities and possessing and leveraging broad industry knowledge.
Responsibilities
Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross‑functional/multidisciplinary therapeutic teams and multidivisional initiatives.
Maintain and evaluate productivity metrics to project current and future business needs.
Align and maintain effective communication channels with key Medical, Marketing, Regulatory, Legal and Public Affairs counterparts. Identify areas of improvement in process/policy, develop recommendations/plan, and lead initiatives.
Assist in managing the departmental budget, identify and communicate budgetary needs to Operations and Finance, and project current and future expenditures and business needs.
Operate independently, with recognition of when to consult departmental senior concerning risks. In absence of Director, is responsible for day‑to‑day operations. Responsible for departmental initiatives, which have significant impact on both internal and external customers.
Encourage innovation and hold employees accountable for delivering on their goals; recognize, mentor, reward and recommend promotion for staff members based on their performance, results, and development.
Exhibit solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals. Possess and leverage broad industry knowledge.
Develop and implement complex processes and projects and deliver strategic presentations for senior management.
Identify areas of improvement in process, policy, develop recommendations/plan and lead initiatives.
This role will work a hybrid work schedule (3 days in office) from our AbbVie Mettawa, IL, Florham Park, NJ or Irvine, CA headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8‑hour day) is required.
Qualifications
Bachelor's degree plus 8+ years of relevant experience (e.g. applicable pharmaceutical/medical devices/biologics experience, pharmacy rotations, public health, etc.).
Advanced degree preferred: MS, MPH, MSN, PA, DNP, PhD, PharmD, JD, MD plus 6 years of relevant industry experience. Certification a plus.
Experience in US Regulatory Affairs Advertising and Promotion highly preferred.
Experience working in a complex and matrix environment.
Strong communication skills, both oral and written.
Experience developing and implementing successful global regulatory strategies.
Experience in management capacity preferred.
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.
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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