Senior Manager, Inspection Readiness, Clinical Compliance & Training

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 of Inspection Readiness, Clinical Compliance and Training will possess strong knowledge of the R&D compliance environment and the broader business impact of compliance issues in order to develop and provide solution-oriented compliance guidance. Responsible for directing inspection readiness and training, identifying compliance risk areas, and communicating such risk areas to management along with action plans to address risks.

Responsibilities:

• Responsible for directing compliance with applicable enterprise, R&D and procurement policies and procedures.
• Develops, implements, modifies, and oversees internal monitoring plans and any corrective actions to ensure compliance with policies and procedures.
• Provides management of R&D compliance, quality and standards projects in coordination with Clinical Development Operations and other stakeholders; prepares key performance indicators
• Provides input new/updates to SOPs, guidelines, work instructions as well as makes initial gap assessments of the impact of new regulations.
• Effectively communicates project progress/ compliance concerns and actively identifies issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues.
• Possesses in-depth knowledge of pharma business.  Leads cross-functional teams on complex issues.

 

Qualifications

Qualifications

• Bachelor’s degree (or equivalent ex-US) is required.
• Must have 7+ years of Pharma-related/ clinical research related experience; 3+ years of experience preferably with clinical research, regulatory, compliance and/or quality control.
• Must have demonstrated a high level of core and technical competence in core subject matter areas e.g., audits, study oversight, SOP development, quality assessments
• Possesses good communication skills and demonstrated leadership abilities and problem solving skills.
• Demonstration of successful coaching/ mentoring in a matrix environment; direct people management preferred
• Considered a Subject Matter Expert and competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
• Experience with global studies from initiation through study completion/primary data analysis and/or in multiple phases of studies (Phase 1 - 4)

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
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.