AbbVie

Standards and Compliance Manager I

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Dec 29, 2020
Ref
2009730
Required Education
Bachelors Degree
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 .

Supports the interpretation and application of GCP and regulatory principles into action in support of Development and business partners to drive execution of high quality clinical trial conduct with minimal supervision. Leads issue management activities for business partners demonstrating excellence in the identification, assessment and delivery of documentation of potential non-conformities, non-conformities, and oversight of effectivity checks with limited managerial oversight. Demonstrates high degree of competence in delivering effective issue escalation and business continuity meetings.

Kay Responsibilities Include:

• Partners with BPO, Functional and Development Leaders to support delivery of program, business process and functional compliance-related deliverables with minimal management oversight. Partner with peers to share best practices and to align in delivery of strategic objectives.

• Able to translates the vision, mission, and operational tactics of Clinical Compliance and apply them to functional deliverables, including but not limited to issue capture, assessment and documentation.

• Oversees compliance metrics for assigned BPO and Function, and delivers on-time and comprehensive compliance metrics to support functional activities and overarching compliance metrics for Sr Leadership and business partners. Using expertise to providing interpretation of possible signals or trends.

• Drive meetings and discussions, managing delivery of actions to closure, and general oversight of the business continuity plan for Development Operations as it impacts areas or BPOs supported with minimal managerial oversight.

• Represents Clinical Compliance in various initiatives within Development Operations or drives initiatives within Clinical Compliance.

• Apply and lead discussions with business partners regarding application of Quality Manual principles in support of the ways we work.

• Effectively manages, prioritizes and balances work activities for areas supported to effectively utilize resources to ensure business needs are met.

• Reviews new and revised regulations, determining and interpreting content and implications with business partners to assess impact to clinical trial conduct and associated processes. Drives discussions with business partners relative during procedural or process changes to ensure regulatory requirements are understood and maintained.

• Delivers Development inspection support provided by Clinical Compliance (inspection support, response review and coordination, evidence review) with minimal oversight

Qualifications

Qualifications :
  • Bachelor's degree (or equivalent ex-US) is required, typically in nursing or scientific field. An Associate's degree/R.N. (or equivalent ex-US)with relevant experience is acceptable. Must have 6+ years of Pharma-related/ clinical research related experience; 2+ years of experience preferably with clinical research, regulatory, compliance and/or quality control. Must have demonstrated a high level of core and technical competencies through management of various aspects of clinical trials (e.g., audits, study oversight, SOP development, quality assessments)
  • Possesses good communication skills, demonstrated leadership abilities and problem solving skills.
  • Demonstration of successful coaching/ mentoring in a matrix environment
  • Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
  • Preferred global exposure from study initiation through study completion in multiple phases of studies (Phase 1-3, 4).

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % 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.