AbbVie

Strategic Global Labeling Manager

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Jan 09, 2021
Ref
2100217
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 Strategic Global Labeling (SGL) Manager has overall accountability for the initial creation and relevant updates to labeling documents for their assigned development and marketed products. This includes global labeling (CCDS/CCSI) and US labeling (prescribing information, patient information and other required labeling components) documents. Development of labeling for these products is based on study results, coordination of labeling reviews within interdisciplinary teams, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with these agencies. The position also includes subject matter expertise in labeling regulations (e.g., FDA labeling rules/guidance) and review of local labeling to ensure global consistency.

Primary responsibilities:
  • Provide project management to the Labeling Sub-Team (LST) leads LST meetings for assigned product, ensuring the timely distribution of preparatory documentation, identification of issues for discussion, preparation of meeting minutes, and follow-up of action items to complete resolution. Provide strategic labeling guidance to authors regarding appropriate content for labeling documents.
  • Assist in the development and review of international local labeling in accordance with the Company Core Data Sheet
  • Interact with business partners and global affiliates in providing strategic guidance as appropriate to ensure consistency and compliance of product labeling.
  • Demonstrate proficient and current labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting evolving FDA regulations and guidance.
  • Maintain knowledge of applicable corporate/company SOPs, guidelines, and working instructions related to product labeling.

Qualifications

Qualifications:
  • Experience drafting and reviewing product labeling, compiling supportive documentation, and demonstrates competence in marketed product labeling maintenance.
  • Basic knowledge of global core data sheet guidance and US regulatory labeling requirements. Relevant experience may include a background in Drug Regulatory Affairs (i.e., FDA liaison) with experience in interpretation of FDA regulations, including exposure to labeling development and maintenance, or a background in medical writing with exposure to FDA regulations as a guide in content development for medical and/or regulatory documentation.
  • Detail-oriented, well organized and good planning skills.
  • Excellent proofreading/editing skills are required
  • Excellent communication (verbal, writing, and presentation) skills necessary for interacting with regulatory project managers and multi-functional labeling review teams.

Education:
  • Graduate degree in scientific discipline, with minimum 1 year labeling or relevant / related experience, Pharm.D. strongly preferred

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.