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Sr. Manager/Manager of Medical Writing

Sr. Manager/Manager of Medical Writing

Job Title: Sr. Manager/Manager of Medical Writing
Contract Type: Permanent
Location: San Diego, CA
Industry:
Start Date: ASAP
Contact Name: Jorge Rios
Contact Email: j.rios@sciproglobal.com
Job Published: February 01, 2021 20:59

Job Description

Our Client, an oncology company containing four clinical-stage assets is seeking a Sr. Manager/Manager of Medical Writing to join their team.

 

About the Role:

  • Reporting to Director of Medical Writing
  • Independently or with minimal supervision write, edit, submit for review, and obtain approval for clinical and nonclinical regulatory documents including, but not limited to, clinical protocols, investigator's brochures, developmental safety reports, and clinical study reports
  • Perform copyediting for grammar, style, and internal consistency

 

Qualifications:

  • 4 + years as a medical writer in a pharmaceutical company supporting regulatory submissions to health authorities, US and/or EU
  • Broad knowledge of clinical development, regulatory affairs, and statistics as applicable to the presentation of clinical data and medical writing
  • Maintains familiarity with current industry practices, regulatory requirements, and guidance related to medical writing
  • Knowledge of AMA style and ICH guidelines

 

Other:

  • Hiring due to growth