Laura Carr Email and Phone Number

•Ensure preparation and execution and reporting of all clinical trial activities •Provide strategic input into the development of the protocols to ensure designs are implementable to efficiently achieve the objectives.•Provide strategic input in the development of CRFs, ICFs, Monitoring Plans, final reports and publications as applicable.•Ensure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)•Have a robust management plan in place before starting a study/ program to ensure optimal control and monitoring, to minimize risks and ensure timely response to treating physicians•Provide oversight of the overall IIS process related to third-party Investigator Initiated Studies IIS as per the Standard Operating Procedure (SOP)•Ensure the IIS process is revisited regularly to adhere to the (SOP) and identify and remediate/correct any gaps on a timely manner to ensure robust preparation and review by the Global IIS committee as well as proper documentation of decisions and document repository•Develop an overarching project management plan •Lead (or delegate to a team member) and manage the global multidisciplinary team to ensure all trial deliverables are met according to timelines, budget, quality standards, SOPs and Business Guidance •Vendor/CRO/Supplier Management•Establish annual objectives for the Clinical Operation group according to GMA priorities •Manage all budgets, contracts, agreements, vendor payments related to clinical trial programs •Ensure regular updates provided to GMAT on trial metrics and data•Establish strong partnership with Regional Operational managers to drive operational excellence in regions and countries for medical affairs clinical activities. •Member of the GMA LT Oncology•Develop and implement process standards and tools to achieve excellence in trial operations and management.

Establish a sustainable process for development and implementation of global policies and procedures for MA activities in collaboration with QA and other stakeholders, including requirement for local implementationCreate a sustainable model for content development and maintenance of Global MA SOPs and AOPs, ensuring appropriate involvement of all key stakeholders across functions and at Global/regional and local level. Serve as lead author, as appropriate Establish & implement process for assignment and tracking of mandatory trainings for GMA associates, in collaboration with QALead activities to operationalize Medical Affairs SOPs and process changes in alignment with key functions and regions to ensure sustainable implementation, as it relates to roles & responsibilities. Implement strong change management plan to promote sustainable culture of quality and compliance focused mindsetDevelop strategic plan to establish infrastructure for proactive oversight of MA activities (self-inspection plan, quality checks, audit/inspection readiness). Ensure scalability as MA activities increase to support 2025 cancer enterprise strategyDevelop a Strategic plan for systems/tools that will be needed to have worldwide view of MA activities and appropriate oversight of performance and quality metricsEstablish KPIs, define/develop clear processes and dashboard for tracking & managing them, ensuring effective status updates at Business ReviewsEstablish & maintain effective communication channels to raise awareness of compliance related matters across global, regional & country medical associatesEstablish a consistent approach to audit, inspection & deviation & CAPA management across Medical AffairsEnsure strong remediation plans for findings and deviations identified during audits, inspections or process control checksLead activities and support GMA team during audits & inspections

•Set the Medical Affairs compliance standards, based on applicable internal policies and regulations, for key operational activities and processes and drive global, regional and local implementation•In collaboration with SME’s, legal, compliance, and CQA, assess compliance risks and gaps related to key Medical Affairs activities.•Identify compliance risks across Medical Affairs and establish a sustainable mechanism to mitigate the risks and ensure compliance across organization. Drive compliance related projects for OMA•Drive change management to promote a sustainable culture and mind set of compliance, across OMA, functions, Regions and countries, and embed it into daily work; identify opportunities to foster alignment and ownership of compliance at the regional and local level•Develop, implement, and deliver training of the appropriate audience across the organization (Global, Regional and local) to ensure full compliance with key policies related to OMA ( P3, Medical Affairs policy; SOPs)•Establish internal controls and metrics to measure effectiveness of processes, trainings and compliance standards•Lead compliance improvement initiatives to further optimize key medical affairs processes in close collaboration with Global Governance Office, Global Drug Development, Global Value Access and Pharma GMA•Lead or participate in cross-functional projects to implement and continuously improve the compliance in OMA and drive optimization of compliance standards to gain sustainability in the business•Establish and maintain effective communication channels to optimize the interface between global, regional and local medical teams; raise awareness on compliance related matters•Work collaboratively with GMA Operations Team to establish appropriate mechanism (including processes, roles & responsibilities) to ensure readiness for Health Authority inspections and internal audits.• Ensure strong remediation plan for any non-compliance findings

•Guide development teams in quality and compliance decision making to drive sustainable quality and compliance excellence•Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA)•Coordinate and review CAPAs to audits to ensure adequate root cause analysis and systemic solutions•Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course•Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures through partnership with personnel, Development Line Functions and Development QA groups•Represent QA in interactions with internal and external contacts and Health Authorities, as appropriate•Ensure inspection readiness by preparing clinical teams for FDA/EU/key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspection•Ensure that compliance commitments are fulfilled on time•Provide interpretation of GCP regulations and company standards , guidelines, policies and procedures to personnel•Drive the implementation of the annual Franchise Quality Plan; identify relevant areas to be addressed in future Quality Plans•Closely cooperate with the Franchise Continuous Improvement/Op Excellence groups; participate and provide Quality and Compliance input for process improvement teams•Closely cooperate with the Development QA Quality Systems Excellence,Auditing and Compliance Excellence groups to ensure consistency of quality and compliance activities and effective communication

•Support the implementation of the Quality Plan in GMA, including Corrective Actions and Preventative Actions (CAPA)•Create, track, report and follow-up to a timely completion all relevant remedial strategies resulting from Corrective Action Plans identified during Audits, SOP deviations, KQI results•Responsible to track and report on GMA Key Quality Indicators (including among others timely CSR completion, registration of protocols and trial results to appropriate registries and required training). Recommend corrective actions and ensure all relevant follow-up activities are completed based upon report outputs. With the Head of GMA, define additional KQI as needed•Represent GMA on cross-functional initiatives aimed at process improvement and ensure a compliance focused environment•Drive change management activities related to the implementation of new processes or organizational changes in GMA•Ensure timely input to SOPs either directly or via assigned GMA SMEs and support operational aspects of SOP training assignments for GMA. Track deviations from SOPs and ensure appropriate documentation is filed, analysis is performed and corrective actions are taken•Systematically sample/monitor adherence to SOPs and standards and plan, perform and coordinate periodic quality control reviews of GMA processes and key deliverables. Report findings and provide remediation planning and support to management and ODQA as appropriate•Implement, manage, track and oversee mandatory training programs for GMA (SOPs and GMA training curricula)•Work with the Head of Operations to address potential quality issues and ensure potential quality issues and emerging compliance concerns are escalated to Head of GMA and ODQA as appropriate•Drive alignment between Oncology GMA (Global HQ) and the Regions and CPOs•Drive compliance within line function to GCP regulations including FDA/EU GCP, ICH, pharmacovigiliance, new drug regulations and other key HA guidance’s.

•Honed skills and knowledge to audit study specific facilities, Contract Research Organizations (CROs), project and other areas as identified by management against the FDA GLP regulations/guidelines, SOPs, protocols, and other governing documents•Developed and maintained required knowledge level of governmentregulations regarding compliance issues and their interpretation as well as industry standards•Accepted assignments for special projects and participated on various departmental and customer committees•Developed skills to operate under departmental SOPs and participated inthe development of departmental SOPs•Plans and conducts routine system “for cause” and “due diligence” audits•Independently identify business practices / compliance issues•Applied basic root cause analysis•Collaborate and communicate within and across the work group.•Maintained accurate audit documentation•Developed and led division audit/ inspection readiness training•Participated as support during FDA, Corporate Audits etc. inspections•Led management / departmental briefings regarding audit/ inspection observations•Utilized Trackwise to track audits and CAPAs