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Lead and manage all Non-Interventional Studies (NIS), including regulatory PMSS and Access Programs, ensuring compliance with corporate and legal requirements. Oversee the medical research operations team, managing workloads, budgets, and the execution of medical initiatives.
Requires a bachelor's degree in pharmacy, nursing, or a scientific discipline with preferably over 7 years of clinical research experience. Must possess strong project management skills and fluency in English for professional communication.
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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
PRIMARY FUNCTION/OBJECTIVE
To lead Team members and activities of all Non-Interventional Studies (NIS) including regulatory PMSS, Access Program(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-country NIS(MCNIS), Affiliate-Sponsored Studies, and IIS Ensure all Non-Interventional Studies (NIS) activities are 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 regarding newly conducted types of studies such as Post Trial Access program, IP supply IIS, Collaborative research, etc. including L-AGN studies, assets.
[Regulatory PMSS]
• Plan and prepare study concept/ protocol in advance to submit them with NDA dossiers. (2-3 years advance 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 subject number adjustment when half of study period is passed, plan for enrollment completion within study period when requested.
PREFERRED QUALIFICATIONS
• Bachelor’s 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.
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, visit https://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
Allergan is now part of AbbVie. 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 LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
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