Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

PRIMARY FUNCTION/OBJECTIVE
To lead Team members and activities of all Non-Interventional Studies (NIS) including regulatory PMSS, AccessProgram(PAA/PTA), Multi-country NIS(MCNIS), Affiliate-Sponsored Studies, and IIS in accordance with relevant SOPs and regulatory requirement.

Manage medical research operations and represent all Non-Interventional Studies (NIS) including
regulatory PMSS, Access Program(PAA/PTA), Multi-country NIS(MCNIS), Affiliate-Sponsored Studies,and IIS operations on cross-functional projects teams, internally/externally.
Responsible and accountable for planning coordination, overseeing, and conducting all NonInterventional Studies (NIS) including regulatory PMSS, Access Program(PAA/PTA), Multi-countryNIS(MCNIS), Affiliate-Sponsored Studies, and IIS Ensure all Non-Interventional Studies (NIS) activitiesare performed according to corporate, ethical, and legal requirements.
Line management and mentoring of medical research & operation team.
Manage workload, plans and resource needs of medical research & operation team.
Proactive planning process experts for study budget planning, LRP, study budget tracking and management
Conduct quality and compliance monitoring in medical research and operation
Operational oversight and execution of medical initiatives/deliverables, monitors status of deliverables and addresses deviation proactively.
Lead and provide guidance, oversight, review as well as come up with the best option regardingnewly conducted types of studies such as Post Trial Access program, IP supply IIS, Collaborativeresearch, etc. including L-AGN studies, assets.

[Regulatory PMSS]
Plan and prepare study concept/ protocol in advance to submit them with NDA dossiers. (2-3 yearsadvance than product launch)
Provide regulatory requirements, estimated budget, realistic target subject number to crossfunctional team when New asset/New indication is discussed.
Estimate and predict if PMSS is completed within given study period and target subject enrollment considering NDA approval/ product launch date.
Develop a strategy how to submit re-examination period for New indication.
Lead and provide guidance, oversight, review regarding preparing reference documents to be submitted to MFDS, specifically target subject suggestion when submitting at first, target subjectnumber adjustment when half of study period is passed, plan for enrollment completion withinstudy period when requested.

Qualifications

PREFERRED QUALIFICATIONS
Bachelors degree and preferably in pharmacy, nursing, or relevant scientific discipline
Significant clinical research experience (more than 7 years-preferred)
Excellent knowledge of clinical research practices, local regulations, and ICH guidelines
Advanced skills in Project Management, particularly, regarding management of schedule, budget,communication, resources, and quality
Experience in people management and leadership, including performance appraisal.
Good interpersonal and effective communication skills and experience developing relationships across functions.
Experience in resource and financial management
Read, write and speak fluently in English, excellent verbal and written communication skills.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html