Medical Research Support Associate
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.
Serves as a Therapeutic Area primary point of contact for externally sponsored and affiliate-run research operations in global Medical affairs. Acts as the Subject Matter Expert for the review, approval, startup, maintenance and closeout procedures related of IIS proposals and Affiliate sponsored studies (i.e.PMOS). <br/>Responsible for the overall tracking and maintenance of the proposal workflow management system and CTMS Databases reporting of study information and metrics. Identifies and escalates performance issues on studies to management and provide recommendations for resolution.
•Responsible for executing all elements of externally sponsored research in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures) (e.g., drug supply management, ICBs, reviews and approves HCP invoices/ payments against executed contracts) with minimal oversight and guidance.
•Responsible for management of clinical essential documents and critical regulatory documents for assigned projects/studies to ensure document packets for study start-up are complete and accurate and consistent with the study start-up timeline.
•Routinely interact with Evidence Leads on assigned projects and in meetings.
•Supports the preparation of Scientific Review Meetings (Agenda/ Meeting Materials).
•Supports on audit/ inspection activities for GCP requirements.
•Responsible for regular updates appropriate for cross-functional team and stakeholders on study status; ensure our CTMS is up to date.
•Participates in process improvement initiatives.
•At least 4-6 years pharma related research experience
•Knowledge of externally sponsored research (IIS, external research collaborations)
•Knowledge of clincical study execution
•Knowledge of Good Clinical Practices and ICH/Guidelilnes, and/or other Global Regulations
•Excellent organizational skills, attention to detail, and strong oral and written communications skills
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
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.