The Associate Manager, Strategic Global Labeling - Operations, is responsible for monitoring activity in COSMOS (Regulatory Information Management System [RIM]) for medicinal products and ensuring the completeness and accuracy of data in the system. Works with Strategists and submission teams by providing appropriate guidance for managing the life cycle of product submissions, applications, and authorization in COSMOS, as described in functional area procedures. Collaborates across therapeutic areas and departments to ensure global consistency of labeling. This role includes supporting the development and/or maintenance of US/EU package inserts, artwork, and Core Labeling Information, including review of these documents with changing regulatory environments.
- Demonstrates ability to apply knowledge in a regulated environment.
- Responsible (with manager’s oversight as needed) for educating internal customers on Regulatory information issues including commercial, public affairs, clinical development, legal, quality and others who contribute to RIM.
- Functions independently in decision making for routine issues.
- In conjunction with manager, reviews complex issues and problem resolution successes and setbacks to assist in future problem-solving applications/options.
- Project Manager responsibility as applicable with Team initiatives, consistently exercising good judgment in the application of policies and regulations. Works well with other individuals and departments in solving problems.
- Participates at team meetings, prepares routine communications for functional area and senior leadership as requested, and meets timelines.
- Subject Matter Expert with business processes for product information management within COSMOS.
- Responsible for accuracy and completeness of tasks within the Artwork Management Systems (AMS) and to ensure compliance with regulatory requirements.
- May indirectly manage the work of other department members. Assists in training of new personnel and in development of department processes/policies.
- Elevates non-compliant records appropriately to the business user or regulatory admin for resolution using AbbVie change management expectations.
- Required Education: Bachelor’s degree in (pharmacy, biology, chemistry, medical technology pharmacology) related life sciences. Associate’s Degree with a minimum of 5-7 years of labeling experience in a Pharmaceutical environment, and Regulatory or Quality-related position with proven record of success can be considered.
- Required Experience: 5+ years in Regulatory Affairs, R&D or related area.
- Experience working in a complex global matrix environment with diverse team members. Excellent communication, both oral and written.
- Strong critical thinking and attention to detail capabilities to quickly and thoroughly evaluate situations and work with management to take appropriate action(s) within defined boundaries of federal and/or local laws, regulations, and AbbVie policies and procedures.
- Preferred Experience: Experience working with electronic regulatory submissions and data standards, prior experience in a regulatory affairs strategy role preferred.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.