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Medical Writer

Company: Surrozen
Location: South San Francisco
Posted on: June 7, 2021

Job Description:

Surrozen is a biotechnology company focused on discovering and developing novel regenerative medicines with a focus on unlocking the powerful self-renewal properties of the body through specific control of the Wnt signaling pathway.

Surrozen was founded by five leading-edge scientists: K. Christopher Garcia, Ph.D., Roel Nusse, Ph.D. and Calvin Kuo, M.D., Ph.D. from Stanford University; Claudia Janda, Ph.D. from the Princess Maxima Center for Pediatric Oncology; and Hans Clevers, M.D, Ph.D. from the Hubrecht Institute and Princess Maxima Center in the Netherlands. Each has conducted extensive research on Wnt signaling, with findings that together shape Surrozen's technology and approach to therapeutic development.

Position Summary

The Principal Medical Writer will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies. The principal medical writer will also support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.

Responsibilities

  • Prepare Investigational New Drug (IND) applications, amendments, briefing documents, annual reports and other documents to support global product development
  • Collaborate with project teams to respond to health authority questions and requests
  • Lead the development and authoring of clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings in collaboration with project teams
  • Contribute to strategic publication planning and implementation of publication plans, including working with internal authors to develop and author manuscripts, abstracts, posters and presentations for scientific congresses
  • Organize, conduct, and lead cross-functional document development meetings from gathering materials and developing content to facilitating document review meetings and discussions and assuring adherence to electronic submission standards
  • Review work of other authors on the project teams for accuracy, quality, focus, and adherence to format and stylistic requirements
  • Develop and implement internal processes, procedures, and templates that support efficient and compliant document preparation

Keywords: Surrozen, South San Francisco , Medical Writer, Other , South San Francisco, California

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