Global Project Management, Innovation and Compliance Function Lead within the Global Regulatory Affairs (GRA) department with seven direct reports. •Set the strategic direction and drive the end-to-end development and the implementation of cross-functional innovation initiatives, transformational projects, budgets and KPIs in close collaboration with business, technical, deployment and vendor teams. •Partner with executive leaders and key stakeholders to translate and drive strategic initiatives and act as a thought partner on key business decisions. Regularly prepare, deliver, and present high quality communication materials to executive leadership and steering committees to enable cross functional dialogue and project proposals.•Lead alliance company integration activities involving the completion of the end-to-end steps of the IND, CTA and NDA transfers involving but not limited to regulatory and legal responsibilities, contract management and wind down activities involving cross functional, cross company and CRO teams.•Lead end-to-end GRA audit and inspection activities to prepare global teams for regulatory audits and inspections and drive an inspection ready culture through the implementation of processes, tools, templates, regular trainings and reminders. •Lead the preparation, review, implementation, and maintenance of GRA controlled procedural documents and trainings as well as monitor training compliance.

•Lead the implementation of innovation initiatives, including establishing and ensuring strong program governance and process management in close collaboration with the strategy and deployment team.•Collaborate with senior leaders within Otsuka Pharmaceutical and other internal and external partners to support effective program planning and execution and ensuring robust change management.•Created and manage a Global Project Management team within Global Regulatory Affairs. •Identify and manage risks and issues, assess the impact of changes and introducing remedial action as required.•Coordinate and track resources across related initiatives to effectively drive to execution.•Support the development of strategic thinking on Otsuka Pharmaceutical's innovation agenda. •Recommend on-going changes to adapt program scope and strategic focus in order to achieve the goals set out in the innovation agenda and for service delivery model transformation to drive long term growth.•Engage with internal and external partners to advance thinking around service delivery and develop primary and secondary benchmarking on market trends and growth opportunities within the industry. •Ensure plans are implemented in accordance with timelines and that any issues, challenges or deviations are escalated for resolution in a timely manner.•Provide high quality communication materials to support executive updates, cross functional dialogue, budget summaries and project proposals.•Support the dissemination of standard methodologies and tools that enable creativity and innovation and lead cross-organizational initiatives that support an expansive culture of innovation at Otsuka Pharmaceutical, including by helping to generate and share new ideas. •Serve as key expert in Innovation framework and process.•Coordinate department meetings and manage project team meetings ensuring communication and organization.

•Drive the implementation of innovation initiatives, including establishing and ensuring strong program governance and process management in close collaboration with the strategy and deployment team.•Collaborate with senior leaders within Otsuka Pharmaceutical and other internal and external partners to support effective program planning and execution and ensuring robust change management.•Identify and manage risks and issues, assess the impact of changes and introducing remedial action as required.•Coordinate and track resources across related initiatives to effectively drive to execution.•Support the development of strategic thinking on Otsuka Pharmaceutical's innovation agenda. •Recommend on-going changes to adapt program scope and strategic focus in order to achieve the goals set out in the innovation agenda and for service delivery model transformation to drive long term growth.•Engage with internal and external partners to advance thinking around service delivery and develop primary and secondary benchmarking on market trends and growth opportunities within the industry. •Ensure plans are implemented in accordance with timelines and that any issues, challenges or deviations are escalated for resolution in a timely manner.•Provide high quality communication materials to support executive updates, cross functional dialogue, budget summaries and project proposals.•Support the dissemination of standard methodologies and tools that enable creativity and innovation and lead cross-organizational initiatives that support an expansive culture of innovation at Otsuka Pharmaceutical, including by helping to generate and share new ideas. •Serve as key expert in Innovation framework and process.•Interface with senior management on an ongoing basis on various core projects and products. •Coordinate department meetings and manage project team meetings ensuring communication and organization.

•Driver of the implementation of innovation initiatives, including establishing and ensuring strong program governance and process management in close collaboration with the strategy and deployment team.•Collaborated with senior leaders within Otsuka Pharmaceutical and other internal and external partners to support effective program planning and execution and ensuring robust change management.•Identified and manage risks and issues, assessed the impact of changes and introduced remedial action as required.•Coordinated and tracked resources across related initiatives to effectively drive to execution.•Supported the development of strategic thinking on Otsuka Pharmaceutical's innovation agenda. •Recommended on-going changes to adapt program scope and strategic focus in order to achieve the goals set out in the innovation agenda and for service delivery model transformation to drive long term growth.•Engaged with internal and external partners to advance thinking around service delivery and develop primary and secondary benchmarking on market trends and growth opportunities within the industry. •Ensured plans are implemented in accordance with timelines and that any issues, challenges or deviations are escalated for resolution in a timely manner.•Provided high quality communication materials to support executive updates, cross functional dialogue, budget summaries and project proposals.•Supported the dissemination of standard methodologies and tools that enabled creativity and innovation and lead cross-organizational initiatives that support an expansive culture of innovation at Otsuka Pharmaceutical, including by helping to generate and share new ideas. •Served as key expert in Innovation framework and process.•Interfaced with senior management on an ongoing basis on various core projects and products. •Coordinated department meetings and manage project team meetings ensuring communication and organization.

Led and managed operational aspects of Phase III clinical oncology trial, ensuring timelines and deliverables were met on time in Japan in accordance with ICH-GCP and applicable local regulations while also providing support to the global clinical trial managers on the study.• Served as the primary contact for all investigators and research personnel in Japan regarding study-specific questions including study timelines, protocol deviations, clinical supplies (central lab kits, manuals and study binders), data retrieval and clean-up, and ongoing patient status updates. •Collaborated with other Regional Clinical Trial Managers and the Global Clinical Trial Manager for global execution of the study. •Assisted with Global Development Operations (GDO) reviews.•Reviewed data and provided findings to senior management, medical director and data management to help identify issues that may impact data base locks. •Facilitated authoring of Investigational Product Information Manual (IPIM) and study specific Important Protocol Deviation (IPD) lists.•Partnered with vendors to ensure study supplies were provided to the sites; reviewed and approved site and vendor invoices.•Compiled IRB/EC submission documentation.•Managed global versioning and distribution of informed consent forms (ICFs).•Created and managed study specific tools such as country retention materials and study newsletters and contributes to the preparation of training materials for the sites.•Facilitated and lead cross functional meetings. •Prepared Clinical Study Team (CST) meeting agendas and minutes.•Maintained and submitted documents to electronic Trial Master File (eTMF) in Veeva.

•Performed investigative site recruitment.•Distributed, collected, processed and maintained essential documents.•Customized and reviewed site-specific informed consent.•Completed, tracked and monitored local IRB/IEC submissions.•Monitored and managed patient recruitment timelines.•Ensured compliance with SOPs, Federal Regulations and data quality.•Served as a primary contact for study investigators and research personnel regarding study-specific questions.•Tracked the status of studies including critical study timelines, patient screening, eligibility, enrollment, study milestones, monitored site frequently asked questions, data retrieval and clean-up, and ongoing patient status.•Comprehensive understanding of in-house site management in accordance with the trial protocol. Sponsor and PRA Standard Operating Procedures (SOPs), and all applicable guidelines and regulatory requirements (e.g. ICH-GCP, country / region specific).•Contributed in achieving high percentages of site activation timelines.

•Comprehensive understanding of Safety Standard Operating Procedures (SOPs), guidance documents and directives associated with reporting drug safety data.•Reviewed adverse events for completeness, accuracy and appropriateness for expedited reporting.•Reconciled adverse event database (Lotus Notes) with information from case report form.•Identified information missing from initial SAE reports and ensured its retrieval.•Coded and assembled documentation for paper and electronic Trial Master File.

Worked as a caregiver to provide the utmost quality of care to Houck’s clients in their homes or facilities by assisting them with activities of daily living. I gained valuable hands-on healthcare experience, the ability to work in dynamic environments, time management skills and the ability to work cooperatively with other aides, nurses and healthcare professionals.

Worked as a caregiver to provide the highest quality of care to the clients in their homes. I assisted the clients with activities of daily living, monitored medicine intake, assisted in simple medical procedures, meal preparation, and companionship. I was able to personally connect with a diverse client population, I gained valuable hands-on healthcare experience, the ability to work in dynamic environments and time management skills.

Actively shadowed a physician assistant for over 500 hours. Performed scribe duties including input of patient electronic health records into nationwide database (EPIC). Uploaded lab results, entered patient history along with the results of the current visit including recording of adverse reactions to the medications. Extracted previous records from the EPIC database (previous lab results, hospitalization, etc.) and provided this information to the Physician Assistant. Observed a variety of complicated patient cases while reviewing patient charts, witnessing patient exams, diagnoses, and treatment plans. Learned medical terminology and also gained knowledge about different diseases and treatment plans. Met and greeted pharmaceutical representatives, listened to their presentations and gained an understanding of the background and rationale of the products.