Medical Research & Operations Manager

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.

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. 

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Work :

No

Employment Type :

Full-time