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

Employer
AbbVie
Location
Lake County, IL, US
Posted
Aug 03, 2018
Ref
1805476
Required Education
Bachelors Degree
Position Type
Full time
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