Remote Clinical Trials Medical Writer & SME for Protocols

RRHS; USA; Remote; USD 77.000 - 92.000; Vollzeit

Zusammenfassung

RRHS is seeking a Medical Writer to interpret complex clinical study protocols and prepare laboratory specifications and study‑specific medical documents for ACM Global Laboratories. You will partner with internal departments to develop, draft, review, and finalize documents used to conduct clinical studies.

This role requires adherence to SOPs and regulatory requirements and the ability to manage multiple document rounds with stakeholders.

Qualifikationen

• BA/BS or equivalent in a scientific field.
• 1 year clinical trials or laboratory experience required.
• Education in medical or technical writing preferred.
• Strong communication skills and ability to influence and collaborate across teams.
• Proficiency in MS Office and desktop publishing.
• Experience drafting clinical trials documentation is a plus.

Aufgaben

• Lead development, revision, and maintenance of complex clinical study documents per SOPs and regulatory requirements.
• Under mentor guidance, draft and revise high-profile study documents and amendments.
• Author and finalize global lab specification documents (GLSD) and related materials.
• Interpret scientific details of protocols and ensure gaps are addressed to satisfy clients.
• Serve as SME for medical documentation across the study lifecycle.
• Coordinate multiple rounds of internal and external document reviews.

Kenntnisse

Strong communication

Team collaboration

Cross-functional coordination

Regulatory knowledge

Ausbildung

BA/BS in scientific field

Education in medical or technical writing

Tools

Microsoft Office

Desktop publishing/word processing

Jobbeschreibung

RRHS is seeking a Medical Writer to interpret complex clinical study protocols and prepare laboratory specifications and study‑specific medical documents for ACM Global Laboratories. You will partner with internal departments to develop, draft, review, and finalize documents used to conduct clinical studies.

This role requires adherence to SOPs and regulatory requirements and the ability to manage multiple document rounds with stakeholders.