PRINEOS S.r.l. - Experienced regulatory medical writers - Remote


Job overview

PRINEOS is seeking medical writers (freelance or full-time employees) with clinical regulatory writing experience to support our teams of Medical Affairs and Biostatistics for a broader range of projects across several therapeutic areas. You will be responsible for delivering high-quality clinical regulatory documents supporting drug development projects. Role is fully remote.

Key responsibilities

  • Draft, review, edit and finalize clinical regulatory documents including, but not limited to, Clinical Study Protocols/Clinical Investigation Plans and amendments, patient Informed Consents, Investigator's Brochures, Investigational Medicinal Product Dossiers (nonclinical and clinical sections), Clinical Study Reports, patient narratives, and clinical overviews and summaries of Common Technical Documents
  • Perform literature searches as needed for drafting document content
  • Interpret and convert relevant data and information into a form meeting clinical regulatory document requirements
  • Ensure timely delivery of high-quality documents
  • Plan, organize and prioritize workload for assigned projects and tasks


  • Bachelor’s degree in life sciences required; advanced degree (MSc, PhD, MD, PharmD) preferred
  • At least 5+ years’ regulatory writing experience across a variety of therapeutic areas in the clinical research
  • Knowledge of ICH-GCP, EU and US regulatory requirements
  • Meticulous attention to detail
  • Ability to work independently and efficiently under tight deadlines
  • Strong organizational and time management skills
  • Excellent verbal and written communication skills
  • Fluent written and spoken English
  • High level of proficiency in using MS Office
  • Proactive and willing to work in a dynamic environment

About the company

PRINEOS S.r.l. is a newly established strategic consulting company offering clinical/biostatistical, regulatory and legal support to organizations in the pharmaceutical, medical device and clinical research fields. We provide Customer-tailored services meeting all project needs: from project design and planning to its development and conclusion, as well as maintenance of its competitiveness.

To apply please submit a cover letter and resume/CV to our HR department ( or click here