Experience

Merck

• Public Relations and Communications Services
• 100 - 200 Employee

• Associate Principal Scientist

  • May 2019 - Present



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Medical Writer

  • Jan 2016 - Present

  Responsible for development of medical writing deliverables that support the clinical regulatory writing portfolio. Independently write, edit and review of clinical study reports, investigator brochures, sections of registration dossier modules, and other clinical regulatory documents. Manage medical writing projects.

• Senior Scientist, Clinical Research

  • Sep 2012 - Jan 2016

  Accountable for the clinical/scientific execution of the clinical protocol. Accountable for the scientific aspects of the implementation and conduct of a clinical trial (e.g., investigator meeting presentations, safety and medical monitoring). Served as the scientific representative on the clinical trial team. Wrote clinical/scientific and regulatory documents. Provided tactical/scientific mentorship to other clinical scientists.

• Clinical Research Specialist

  • Feb 1998 - Sep 2012

  Coordinator/support role for the scientific conduct of a clinical protocol. Assisted the Program Lead and study team with the scientific conduct of clinical studies. Performed specific task assignments , e.g, adjudication support, medical monitoring, data management deliverables, preparation of meeting materials, safety and medical monitoring. Interacted with internal and external stakeholders (study sites, committees, etc) in support of clinical study objectives.



Thomas Jefferson University Hospitals

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Special Lab Assistant

  • 1994 - 1997