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 21,000 people worldwide and markets medicines in more than 170 countries.
PRIMARY JOB FUNCTION:
Critically reviewing document content to ensure accuracy and completeness in order to authorize release of investigational product (IP) to study sites. Ensuring required site documentation remains current during the conduct of a study, and providing safety and relevant study updates to the IRB. Managing the Trial Master File (TMF), ensuring documents maintained in the file are appropriate and the content of those documents is accurate, complete and consistent with Abbott SOPs and regulatory requirements. Preparing sites for Site Initiation Visits (SIV) by ensuring initiation supplies are available. Tracking and reporting site/study status to the Clinical Team. Participating in the preparation activities required for regulatory and QA audits. Coordinating the distribution of communications to all sites (e.g. questionnaires, newsletters, mass mailings, etc). Managing the translation and tracking of translations for appropriate study documents. Ensuring all required documentation has been obtained by Abbott and is also available in the Investigators Site File. Ensuring IP accountability documentation is complete, allowing for successful reconciliation. Submits required documentation for completion of a Clinical Study Report (CSR) or inclusion in a regulatory filing. Manages study related activities in tandem with the clinical team and/or Field Operations by ensuring IMPACT is up to date for areas of responsibility. The Individual must be able to: Identify potential compliance gaps. Take initiative and identify new approaches to resolve problems and mitigate risks.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Entry-level position in which the incumbant is expected to learn and master: Clinical document management and tracking skills. Effective interaction with Abbott professionals, external sites and vendors. Task prioritization and timeline adherence. Abbott electronic systems and tools (e.g., IMPACT, eDocs, GEARS, Zephyr, etc.) Maintenance of an audit- and archive-ready trial master file.
POSITION ACCOUNTABILITY / SCOPE:
Accountable to Clinical Team in designated area(s) and Field Operations for meeting established timelines. Accountable to Document Management organization for adhering to processes and procedures. Accountable to Clinical Operations for the management of a Trial Master File that is compliant with Abbott SOPs, Document Management Training Requirements, and Regulatory Guidelines.
BA, BS or RN preferred. HS diploma or equivalent acceptable with prior Pharma experience.
0-2 yrs Pharma experience or professional equivalent. Demonstrates analytical and critical thinking skills. Possesses presentation and communication skills.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)