Zentalis Pharmaceuticals
Published
November 2, 2021
Location
San Diego, CA
Category
Other  
Job Type
Work Setting
In-office

Description

Reporting to the Senior Director of Medical Writing, the Medical Writer is responsible for developing high-quality, scientifically accurate clinical and regulatory documents according to international regulatory requirements and internal document standards. This role involves interactions on a regular basis with members of internal departments.

RESPONSIBILITIES

  • Writing and integration of appropriate clinical data into protocols, investigator brochures, clinical study reports, and other clinical and regulatory documents, with input from functional area experts.
  • Coordinating the overall development and finalization process for assigned documents, including developing and driving timelines, hosting document review and comment resolution meetings, and obtaining approvals.
  • Building and maintaining relationships with study team members, which include representatives from internal departments such as Clinical Development, Clinical Operations, Regulatory Affairs, and Biostatistics.
  • Representing medical writing on project teams and actively participating in interactions and providing feedback on data description, presentation, and analysis.
  • Review documents for clarity, accuracy, and consistency between documents.
  • Developing and maintaining in-depth therapeutic and product knowledge.
  • Providing quality control review of various clinical and regulatory documents.
  • Advance the medical writing group via the development of writing processes and working standards.

QUALIFICATIONS

  • BS/BA required; Master’s/PhD/PharmD in life sciences preferred.
  • Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and/or clinical data.
  • Strong project management and leadership skills; ability to coordinate the efforts of team members according to timelines.
  • Strong attention to detail and drive to produce high-quality documents.
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