Senior Manager, RA Strategic Global Labeling (Oncology)

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.

The Senior Manager Labeling RA, Strategic Global Labeling, develops and maintains US package inserts, European Union (EU) Summary of Product Characteristics (SmPC) and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. Mentors and educates cross-functional team members concerning global consistency of labeling with minimal supervision for more complex material but generally functions independently. Develops and presents strategy to management and leads a team to successfully execute regulatory strategies within a therapeutic area. Works with several cross-functional teams and often at director level. Supports multiple therapeutic areas and effectively leads cross-functional groups in the completion of project tasks and sub-projects. May manage direct reports.

Responsibilities:

• Leads teams on labeling decisions based on knowledge of processes and regulations and precedence. Educates others as to new labeling regulations regarding Company core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SPC) Structured Product Labeling (SPL), or Instructions for Use (IFUs).
• Reviews and assesses data to determine whether accurate and reproducible. Works with clinical and safety teams to assure revised data is included as support documentation following approvals. Works with cross-functional teams and affiliates to address Ministry of Health (MOH) requests globally in a timely manner.
• Drives strategic labeling processes within teams based on knowledge of success with other products. Proactively recommends optimal label language based on competitive knowledge and knowledge of project data.
• Maintains accurate files of labeling change history and associated documents, including annotated labels back to source data. Ensures that direct reports are current with maintenance of their documents. Works with Labeling Operations to ensure quality documents are internally maintained or submitted to FDA.
• Participates at team meetings, reviews materials, authors documents, trains staff, manages direct reports, meets timelines.
• Leads cross-functional teams to resolve labeling issues and coaches direct reports on their issues.
• Works with safety groups on safety issues and leads discussion on safety-related labeling changes. Makes decisions on own topics and those of direct reports based on experience with various products. Understands and supports regulatory implications of product profile. Works strategically with TA and safety to maintain an accurate safety profile for assigned products. Provides labeling input for Risk Management Plans and safety documents
• Independently will provide labeling support to affiliates including pre-approvals, renewals, and competitive analysis and reviews work of direct reports.
• Presents process, strategy, and product labeling at Senior level meetings (Regulatory Strategy Review (RSR), Executive Labeling Committee (ELC), Common Technical Document (CTD) steering committee) and joint company meetings, under the direction of the Director, Strategic Global Labeling.

Qualifications

Qualifications:

• Required Experience: 7 years in pharmaceutical, regulatory, R&D or related area. Experience in labeling or area that could link to labeling 
• Required Education: Bachelor’s degree in Pharmacy, Biology, Chemistry, pharmacology or related
• Preferred Education: Bachelor’s degree. Certifications a plus
• Ability to supervise projects and set daily priorities. Able to work in a complex and matrix environment
• Preferred Experience: 4 years in pharmaceutical or regulatory preferred. Minimum 4 years’ experience in clinical or pharmaceutical preferred
• Cross-divisional team experience and working with cross-functional teams 
• Strong problem solving with minimal guidance

 Note: Higher education may compensate for years of experience

 

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % 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.