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- Kierownik / Koordynator
Reports to Head, CTA Liaison, GRA, Global Regulatory Operations Submissions Management Direct line, management of Global and/or Regional CTA Submission Managers within/across regions. Close partnership with Global, Regional and Country Regulatory Leaders, Clinical Study Management and Business Process Owner, CTA's
Accountable for the operational Delivery of the CTA portfolio: Line Manager for global and regional CTA SMs responsible for the logistical execution of regional and national Clinical Trial Applications, both initial and lifecycle for multiple regulatory authorities while ensuring conformance with compliance requirements and time, quality and standards.
Drive management of regulatory requirements pertaining to CTA's for all countries outside US, Canada and Japan* and for all multi-country project applications through all phases.
- Act as Line Manager to CTA SMs delivering support, guidance and manager performance through one to ones and team deliverables
- Define, develop and lead a GRO-SM CTA 'hub' through close partnership with Regulatory Stakeholders, GRO SM Hub leads and Business Process Owner, CTA's.
- Set vision, strategy, cycle times and performance objectives for the operational process and ensure proper process documentation is robust and accurate.
- Champion and drive process excellence whether driven by improvement, regulation, or change in operating model.
- Implement strategies that achieve operational excellence through interaction with regulatory leaders and asset / study teams within designated Business Units, ensuring alignment of submission strategies, key objectives and learning outcomes.
- Accountable point of contact with internal customer base.
- Coach, mentor and develop colleagues.
- Provide input to CTA scenario planning, timeline predictions, outcomes and activity management to underpin informed decision making of the study team.
- Establish and maintain appropriate metrics to ensure compliance, and acceleration of timelines through study start and lifecycle maintenance
- Extensive line management experience at required level to enable thorough understanding of the responsibilities associated with evolving business processes
- Ability to transform ambiguous situations/discussions into structured outcomes
- Management of change in partnership with key stakeholders
- Significant experience working as part of a global product team or Therapeutic Area developing and delivering products across multiple markets.
- Bachelor's Degree or equivalent required; advanced degree preferred. Experience with strategic business planning and leading an international organization is required