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Esther Rapoport's email & phone number

Manager & Innovation Lead, Global Regulatory Affairs at Otsuka Pharmaceutical Companies (U.S.)

Esther Rapoport's Email Addresses & Phone Numbers

Esther Rapoport's Work Experience

Otsuka Pharmaceutical Companies (U.S.)

Global Project Manager & Innovation Lead, Global Regulatory Affairs

March 2018 to June 2019

Princeton, New Jersey

Otsuka Pharmaceutical Companies (U.S.)

Global Project Manager, Global Regulatory Affairs (Contractor)

June 2017 to March 2018

Princeton, New Jersey

Amgen

Associate Clinical Project Manager

May 2016 to June 2017

North Wales, PA

Esther Rapoport's Education

The George Washington University School of Medicine and Health Sciences

Master of Science - MS, Clinical Research Administration

2017 to 2019

Rutgers University

Big Data Certification

2018 to 2018

Mercer County Community College

Certificate in Clinical Development and Regulatory Affairs

Esther Rapoport's Professional Skills Radar Chart

Based on our findings, Esther Rapoport is ...

Charming
Purposeful
Initiating

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Based on our findings, Esther Rapoport is ...

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Esther Rapoport's Estimated Salary Range

About Esther Rapoport's Current Company

Houck Home Care

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.

Frequently Asked Questions about Esther Rapoport

What company does Esther Rapoport work for?

Esther Rapoport works for Houck Home Care


What is Esther Rapoport's role at Houck Home Care?

Esther Rapoport is Caregiver


What is Esther Rapoport's personal email address?

Esther Rapoport's personal email address is es****[email protected]


What is Esther Rapoport's business email address?

Esther Rapoport's business email address is [email protected]***.***


What is Esther Rapoport's Phone Number?

Esther Rapoport's phone (201) ***-*132


What industry does Esther Rapoport work in?

Esther Rapoport works in the Pharmaceuticals industry.


About Esther Rapoport

📖 Summary

Global Project Manager & Innovation Lead, Global Regulatory Affairs @ Otsuka Pharmaceutical Companies (U.S.) •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. From March 2018 to June 2019 (1 year 4 months) Princeton, New JerseyGlobal Project Manager, Global Regulatory Affairs (Contractor) @ Otsuka Pharmaceutical Companies (U.S.) •Drove 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. From June 2017 to March 2018 (10 months) Princeton, New JerseyAssociate Clinical Project Manager @ Amgen Lead 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. From May 2016 to June 2017 (1 year 2 months) North Wales, PAIn-House Clinical Research Associate @ PRA Health Sciences •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. From November 2015 to May 2016 (7 months) Blue Bell, PennsylvaniaDrug Safety Assistant @ Covance •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. From August 2014 to November 2015 (1 year 4 months) Princeton, NJCaregiver @ Houck Home Care 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. From March 2014 to January 2015 (11 months) State College, PennsylvaniaCaregiver @ Care Plus More, Inc. 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. From June 2014 to December 2014 (7 months) Washington Crossing, PAShadowing and performing Scribe duties @ Temple University Health System 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. From June 2010 to August 2013 (3 years 3 months) Philadelphia, PA


Esther Rapoport’s Personal Email Address, Business Email, and Phone Number

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Esther Rapoport's Ranking

Ranked #163 out of 3,256 for Caregiver in New Jersey

Esther Rapoport's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

1 year(s), 3 month(s)

Esther Rapoport's Willingness to Change Jobs

Unlikely

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