Remote Medical Writer: Regulatory & Clinical Reports

RQM+; Polska; Remote; PLN 60.000 - 90.000; Vollzeit

Zusammenfassung

RQM+ in Poland is seeking a Medical Writer to develop Clinical, Scientific, and Regulatory documents for EU MDR, IVDR, US FDA, and other regulatory requirements for RQM+ clients. You will conduct literature reviews, write Clinical and Post Market regulatory documents, and analyze information from various sources.

You will collaborate with cross-functional teams to gather and interpret clinical and safety data, stay current with evolving global regulations, and ensure documents follow RQM+

Qualifikationen

• Residence in Poland is required.
• 0–2 years of medical writing experience.
• Bachelor's/Master's/PhD in a relevant field.
• Strong medical and technical writing skills.
• Familiarity with research software and databases (Endnote, PubMed).
• Excellent organizational skills and ability to manage multiple projects.

Aufgaben

• Assess clinical data for evidence of validity, performance, and safety.
• Prepare, write, edit, and review regulatory clinical reports (Clinical and Performance Evaluations, Clinical Study Reports).
• Perform literature searches for Safety/SotA and review findings.
• Collaborate with cross-functional teams to analyze and interpret data.
• Stay current with global regulations and guidance and communicate impact internally and to clients.
• Ensure documents conform to RQM+ procedures and guidelines.

Kenntnisse

Medical writing

Regulatory writing

Scientific writing

Attention to detail

MS Office

Independent work

Ausbildung

Bachelor’s / Master’s / Ph.D.

Tools

Endnote

PubMed

Jobbeschreibung

RQM+ in Poland is seeking a Medical Writer to develop Clinical, Scientific, and Regulatory documents for EU MDR, IVDR, US FDA, and other regulatory requirements for RQM+ clients. You will conduct literature reviews, write Clinical and Post Market regulatory documents, and analyze information from various sources.

You will collaborate with cross-functional teams to gather and interpret clinical and safety data, stay current with evolving global regulations, and ensure documents follow RQM+