Description
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 28,000 people worldwide and markets medicines in more than 170 countries.
PRIMARY JOB FUNCTION:
- CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Provide medical review of safety protocols, and clinical brochures.
Serve as sub-investigator or primary investigator for Clinical Pharmacology and Phase 1 clinical studies.
Monitor and summarize clinical adverse events; maintain all aspects of medical safety for product lines.
Evaluate safety data involving INDs/NDAs and provide interim and final analyzing of reports for such projects.
Maintain liaisons with, and provide evidence based advice to Quality Assurance, Document Management, Clinical teams, Legal, and Regulatory Affairs.
Manage and mentor clinical research team members as required by assigned projects.
POSITION ACCOUNTABILITY / SCOPE:
Requirements
Basic Qualifications:
Minimum of 1 year of clinical experience within a pharmaceutical company, private practice, academic, or CRO setting, especially as related to clinical pharmacology or early phase clinical development
Familiarity with FDA organization, and experience with FDA inquiries involving drug safety and efficacy including the ability to review safety and labeling protocols.
Administrative ability; strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required.
A physician with U.S. board certification in Internal Medicine, Emergency Medicine or Family Medicine, and active US license that is transferable to State of Illinois within 3 months.
Preferred Qualifications:
Clinical research experience within a pharmaceutical or CRO clinical pharmacology setting.
Experience working in project oriented cross functional and matrix teams
Education Requirements: US: Medical Doctorate (M.D.) degree or equivalent (D.O.) or non-US equivalent.
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