Latoya H.

About Latoya H.

I bring a robust and diverse background in the biopharmaceutical industry, with a strong focus in clinical development. Currently, I serve as Medical Writing Operations Senior Manager at Pfizer, where I lead strategic initiatives supporting clinical documentation excellence and cross-functional collaboration.Prior to Pfizer, I held impactful roles at Seagen and Regeneron Pharmaceuticals, Inc. At Seagen, I provided the Medical Writing team with project management, operational oversight, and technical support. At Regeneron, I contributed to the Medical Affairs department, focusing on Clinical Publications Management operations, ensuring timely and compliant dissemination of scientific data.My career also includes experience in consumer healthcare and marketing, having worked with two direct marketing agencies and The Nielsen Company, supporting clients such as Pfizer (CPG), Unilever, and Verizon.I hold a Doctorate of Medical Science in Healthcare Leadership and a Master of Science in Regulatory Affairs from Northeastern University, along with a Bachelor of Science in Marketing from Morgan State University.My doctoral research—\"Addressing Health Literacy in the Black Population to Maximize Pharmacovigilance for Public Safety\"—was prominently featured in the Health section of the KONBIT 2025 presentation before an international audience. The research emphasized how language barriers, particularly among Haitian Creole-speaking patients, can lead to misunderstandings about medication use and increase the risk of adverse events (AEs). This insight was central to the presentation’s health focus on advancing public safety and equitable healthcare communication in clinical workflows.I continuously build on this foundation through professional development, earning certificates from:Yale University – Essentials of Global HealthJohns Hopkins University – The People, Power, and Pride of Public HealthVanderbilt University – Enhancing the Recruitment of Minorities in Clinical TrialsIndiana University – Generative artificial intelligence (GenAI 101)Beyond my professional work, I am deeply committed to community upliftment. I actively volunteer with charitable organizations and mentor aspiring professionals. My contributions were honored in the 10th edition of Who’s Who of Black Charlotte.As an engaged member of several STEM and healthcare organizations, I’m always open to connecting with like-minded professionals. Feel free to reach out to explore collaboration, mentorship, or networking opportunities.

Experience

1. Medical Writing Operations Senior Manager

   Pfizer

   Dec 2023 — Present

   Provides strategic guidance to medical writing vendors and study teams on standard processes for preparing plain language study results summaries (PLSRS), safety narratives, and related deliverables within the scope of Medical Writing. Ensures compliance with regulatory requirements, including the European Union Clinical Trials Regulation (EU CTR) No. 536/2014, which mandates the provision of clinical trial results in a format understandable to laypersons.• Plans and manages project timelines to ensure that vendors complete deliverables within agreed-upon timelines. Identifies, communicates, and resolves issues affecting project timelines.• Manage routine vendor interactions, including preparation of work requests, procurement of access to internal systems, and monitoring of training compliance. Attend regular operational governance meetings with vendors. Assist management with forecasting by generating and/or reviewing reports from internal systems. • Facilitate inspection readiness for processes in SOPs (Standard Operating Procedures)/Work instructions (WIs) used by Medical Writing. Review documentation in trial master file and other systems associated with the CSR SOP. Respond to document requests before and during inspections. Leading role in the development of responses or corrective actions/preventive actions (CAPAs), as needed. • Support vendor oversight by collecting and reviewing document quality metric data from vendors.• Supports continuous process improvement by collecting and reviewing document quality metric data from vendors to identify trends or issues. Leads workstreams in collaboration with management to develop and implement remediation plans.

Education

• Northeastern University

  Doctor of Medical Science, Healthcare Leadership with a concentration in Patient Safety

• Northeastern University

  Master of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices

• University of South Florida

  Certificate, Diversity, Equity and Inclusion

• Morgan State University - Graves School of Business & Management

  Bachelor of Science, Marketing