Associate, Clinical Trial Disclosure
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.
Job Title : Associate, Clinical Trial Disclosure
Assists the Clinical Trial Disclosure (CTD) area with the execution of AbbVie clinical drug trial registration (primarily) and results disclosure postings per the applicable regulatory and Standard Operating Procedure SOP) requirements.
- Works closely with/supports the Senior Associate, CTD and Manager(s) of CTD: to determine the AbbVie drug trials required to be registered and results disclosed, to effectively communicate this information and related timelines to the applicable individuals involved in these activities, to provide guidance to and build cross-functional collaborative relationships, to coordinate the completion of these activities to achieve/ensure timely disclosure of accurate and complete information.
- Works closely with/support the Senior Associate, CTD and Manager(s) of CTD in operationalizing changes in both the US and International regulatory environment via participation in the development and implementation of SOPs/processes as well as creates efficiency improvements/furthers system automation and related communication and training activities.
- Participates in CTD compliance prevention by providing QC checks and metrics as requested.
- Maintains/tracks CTD for AbbVie clinical drug trials, including the documentation and storage of the information.
- Cross-trains with other CTD staff.
- Accountable for meeting the main objectives of assigned projects/roles and responsibilities within established timelines and with an appropriate quality level.
- Accountable to Senior Manager, CTD. Act as a key contributor, who exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
- Daily interaction with Senior Associate, CTD and/or Manager(s) of CTD as well as significant interface/communication with cross-functional areas.
- Expedient escalation of issues to management is essential and may have a direct impact on CTD compliance.
- Bachelor's degree (BA/BS) from an accredited college or university is required, preferably in a health or biological science field.
- Must have 2+ years of clinical research experience or experience in a related area such as quality or regulatory and working knowledge of drug development.
- Must be familiar with ICH and GCP Guidelines and have good organizational and communication skills and competent in application of standard business procedures (SOPs/Work Instructions, OEC).
- Must have the ability to prioritize roles and responsibilities daily and work well under deadline pressure in a team environment in order to execute goals to ensure they are achieved (i.e. maximizes individual skills utilizing the collective skills of the CTD area).
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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.