AbbVie Assistant Director, Clinical Compliance - (Remote Work Schedule Option) in Lake County, Illinois

Assistant Director, Clinical Compliance - (Remote Work Schedule Option)

USA, Illinois, Lake County

Research & Development

Requisition #1805476

Provides tactical and strategic clinical compliance oversight and direction ensuring collaboration across functional areas to translate regulations/ requirements into the execution of high quality clinical trial conduct.

Ensures tracking and implementation of commitments from inspections.

Key Responsibilities Include :

  • Responsible for compliance with applicable Corporate and Divisional policies and procedures.

  • Provide tactical and strategic oversight of clinical trials to ensure compliance across all Therapeutic Areas/ Clinical Operations

  • Develop and assess cost, resource projections and metrics for the function

  • Integral participant during regulatory inspections and process improvement initiatives.

POSITION MAY BE FILLED AT LEVEL COMMENSURATE WITH EXPERIENCE

Basic:

  • 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 10+ years of Pharma-related/ clinical research related experience (and/or applicable work experience); including 6 years (and/or applicable work experience); in clinical research demonstrating a high level of core, technical and leadership competencies through setting and driving strategy and leading a global team

  • Possesses good communication skills and decision-making skills

  • Demonstration of successful coaching/ mentoring and people management (remote management experience preferred)

  • Considered a Subject Matter Expert and competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)

  • Integral participation in initiatives or advancement strategies for clinical operations

Travel:

50% travel