Scientific Writing Manager

3 weeks ago


San Diego, California, United States Aroga Biosciences Full time
About Aroga Biosciences

Award-winning Contract Research Organization (CRO) based in San Diego, CA, specializing in regulatory writing and submission services for biotech and pharmaceutical projects.

Job Description

We are seeking a highly experienced Manager, Scientific Writing to oversee scientific writing projects and writing teams. The ideal candidate will have a strong background in scientific writing, medical communications, and/or medical writing, with experience in writing and reviewing regulatory documents, particularly IND experience.

The successful candidate will be responsible for:

  • Developing high-quality regulatory documents, such as study reports, M2 summaries, early stage clinical protocols, and Investigator's Brochures
  • Grant writing and manuscripts
  • Collaborating with cross-functional teams, reviewing and interpreting data, and ensuring compliance with regulatory guidelines and requirements

The role is primarily based in San Diego, CA, with flexibility for some remote work. We offer a competitive salary, comprehensive medical benefits, flexible work week, and 401K options.

Requirements:

  • M.S., Ph.D., Pharm.D, M.D., or equivalent degree
  • Scientific Writing, Medical Communications, and/or Medical Writing skills
  • Experience in writing and reviewing regulatory documents, particularly IND experience
  • Strong research and analytical skills
  • Excellent written and verbal communication skills
  • Attention to detail and ability to meet tight deadlines
  • Knowledge of regulatory guidelines and requirements


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