Inez Ruiz-White, PhD

Experience

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  Thomas Jefferson University

  Jan 1997 - Jan 2003

  Graduate Student
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  Cleo Cosmetic and Pharmaceuticals

  Apr 2003 - Dec 2006

  Senior Scientist

  Principal lead scientist of two separate ophthalmic research projects involving corneal preservation for corneal transplantations and posterior capsule opacification. Responsibilities included:• managing the research department• establishing and validating in vitro and ex-vivo assays to identify specific components essential for the corneal preservation media formulation• writing a SBIR grant for NIH funding• generating preclinical data for the pursuant of licensing opportunities• preparing various documentation/reports including all testing procedures/SOPs, monthly progress reports, and internal proposals• collaborating with regulatory affairs for 510K application submission to FDA.Major accomplishments included:(1) Successfully developed a corneal preservation media that can preserve cornea viability for at least two weeks. Show less

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  Rowan University

  Sept 2003 - Jan 2023

  Adjunct Professor

  Lecture on biology topics such as cellular organization, cellular respiration, organ systems, evolution, cell reproduction, cell division, and genetics.

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  Genaera

  Jan 2007 - Apr 2009

  Assistant Director of Research

  Major responsibilities include: (1) directing in-vitro and in–vivo studies investigating the mechanism of action of lead candidates(2) serving as project leader for the quantitative structure-activity relationship (SAR) program(3) serving as project leader for the development of drug formulations.

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  Evo Tx

  May 2009 - Jan 2012

  Scientific Writer Consultant

  Reported directly to the Managing Partner.Major responsibilities included: (1) writing scientific abstracts(2) construction of SBIR grants(3) interacting with collaborative scientists/clients to obtain relevant information

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  Forest Laboratories

  Jan 2010 - Jan 2012

  Medical Writer Consultant

  •Prepared patient narratives for CSRs.•Wrote and prepared sections involving pharmacology and efficicacy for CSRs, investigator brochures (IBs), and INDs

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  Johnson and Johnson

  Jun 2010 - Jul 2011

  Scientist, Pharmacovigilance Aggregate Reporting

  •Managed the production of aggregate reports (Periodic Safety Update Reports, Summary Bridging Reports, and Addendums) for assigned products including planning and conducting meetings, writing, coordinating production and modification, addressing questions, and assembling in documentum.•Performed quality review for pharmacovigilance peer reports.•Provided support and worked within a team to assure pharmacovigilance reports remained compliant with regulatory agencies.

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  Merck

  Jul 2011 - Jun 2013

  Aggregate Report Manager

  • Responsible for overseeing the production of aggregate reports including PSURs, PBRER, DSURs, Summary Bridging Reports (SBRs), Suspected Unexpected Serious Adverse Reaction Line Listing Report (SUSARs) and Addendums Reports (ARs)• Managed medical writing activities• Managed safety report submissions to the European Union• Responsible for assuring the department is compliant with regulatory agencies and guidelines.

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  Otsuka Pharmaceutical Companies (U.S.)

  Jun 2013 - Nov 2022

  • Report directly to Chief Medical Officer• Partner with R&D leadership to define strategic imperatives • Recommend and build initiatives and tactics based on strategic imperatives• Lead internal projects across the R&D organization related to DE&I efforts • Monitor progress of strategic imperatives, promote senior leadership dialogue/ debate and escalate issues for resolution, as needed• Serve as a liaison between enterprise, R&D and commercial work streams; identify and eliminating any redundancies and harmonizing and coordinating work between parallel initiatives• Gather, analyze, and present data and metrics, utilizing data-based evidence to measure progress and to improve DE&I strategies and plans • Collaborate, contribute to and/or represent Otsuka with external consortiums and industry programs specific to DE&I within R&D Show less • Directed global team of pharmacovigilance safety scientists.• Developed the global risk assessment and signal management process for medical safety• Coordinated, directed, and trained global team responsible for signal management and safety reporting• Lead process improvements in safety assessments, health authority responses, safety governance, labeling, and quality reviews. • Served as Subject Matter Expert for signal and risk management, Aggregate Reporting, and Safety Governance • Served as Subject Matter Expert in audits and inspections• Developed and utilized visualization tools & systems to support safety assessments• Participated in various cross-functional activities such as:o safety governance forumso clinical trial development and safety monitoringo submission of new drug applications and filingso pharmacovigilance agreements (PVAs). Show less • Assisted medical safety staff (Physicians & Scientists) with monitoring the safety profile of assigned Otsuka investigational & marketed products including devices and combination products through the use of clinical, pharmacological & epidemiologic knowledge.• Participated in the evaluation of safety data, conducted risk analysis, and reviewed adverse events according to GCP and regulatory guidelines, in order to protect the safety of patients.• Authored safety sections for pre- and post-marketing aggregate reports and other key safety documents, including safety data summaries, NDA, SUSAR LL, PADER, PBRER/PSUR, DSUR, RMP, etc. • Participated in business integration processes (development, implementation & evaluation), process improvement work-streams and other department initiatives; attended inter-departmental meetings and assigned to committees as appropriate.• Collaborated with the medical safety physicians to review and author clinical safety documents associated for assigned product/compound (e.g., IND/NDA Periodic, CSR, Summary Analysis, tables & listings, etc.) and accompanying data for completeness, consistency, accuracy and clarity. Show less

  • R&D Lead of Diversity, Equity, & Inclusion (DE&I)

    Jun 2021 - Nov 2022

  • Director of GPV Risk Evaluation and Reporting

    Jun 2017 - Jun 2021

  • Associate Director of Medical Safety Operations

    Oct 2013 - Jun 2017

  • Medical Writer

    Jun 2013 - Oct 2013
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  Daiichi Sankyo, Inc.

  Nov 2022 - now

  Director of Risk Management, CSPV

  Charged with leading a global center of excellence for risk management and risk assessment that would support a global CSPV department.