AbbVie · 3 hours ago
Senior Manager, Regulatory Affairs US Advertising & Promotion (remote)
Mettawa, IL
Full-time
Remote
Senior Level
7+ years exp
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Responsibilities
Reviews promotional and non-promotional communications for on-market products to ensure compliance with applicable laws and regulations, as well as internal policies and procedures. Functions independently in this role while bringing relevant topics to management as appropriate.
Provides regulatory guidance for data and information consistent with product labeling.
Participates in pipeline commercialization activities; reviews and contributes to target product claims, target product labeling.
Acts as a key contributor on cross-functional teams and workstreams for pipeline and on-market products.
Develops and guides implementation strategies for promotional activities.
Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within US Advertising and Promotion department.
Represents department and participates in trade associations as needed.
Summarizes findings, under supervision, in concise reports for distribution within AbbVie
If assigned staff, oversees their operations, productivity, and development.
Ensures departmental training and compliance with established regulations, FDA guidance, promotional guidelines, and SOPs related to advertising and promotion regulations. If applicable, manages direct reports and assist in the development, training and mentoring of staff members
Effectively presents pertinent information to appropriate cross-functional groups.
Effectively delivers difficult messages to commercial organization while maintaining relationships.
Establishes good working relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Market Access, Public Affairs, etc.), fostering mutually beneficial interactions and exchange.
Qualification
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Required
Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology pharmacy, pharmacology, nursing, pharmacy)
Experience working in a complex and matrix environment and exhibits strong negotiation skills.
Strong communication skills, both oral and written
Preferred
Relevant Master’s degree (Pharmacy, advanced scientific or law)
7 years pharmaceutical experience in Regulatory Affairs or related area
Experience in management capacity
Experience in US Regulatory Affairs Advertising and Promotion
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
AbbVie
AbbVie is a pharmaceutical company that discovers, develops, and markets medicines. It is a sub-organization of AbbVie.
10,001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (155)
2022 (299)
2021 (194)
2020 (197)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO· undefined
Leadership Team
Robert Michael
Chief Executive Officer
A
Azita Saleki Gerhardt
Senior Vice President, Operations
Recent News
2024-11-26
Company data provided by crunchbase
