Senior/Principal Medical Writer (remote, Poland) responsible for end-to-end development and QC of clinical study documents—protocols, IBs, ICF templates, DSURs, CSRs, and patient narratives—ensuring compliance with Precision MW style, SOPs, ICH/FDA/GCP guidance, clinical trial transparency and eCTD requirements. Role involves independent data interpretation, authoring complex content, contributing to SOPs/templates, performing literature research, and collaborating with sponsors, vendors, and internal teams. Minimum 5+ years’ senior medical writing experience (or 7+ years as Principal).

Senior/Principal Medical Writer responsible for planning, authoring, editing, formatting, and QC of clinical study documents (protocols, IBs, ICFs, DSURs, CSRs, patient narratives), ensuring compliance with Precision SOPs and regulatory guidance (ICH, FDA, GCP) and eCTD requirements. Requires a BS in a scientific/medical discipline and at least 5 years' experience as a senior medical writer (or 7+ years as principal), proficiency with Microsoft Office and Adobe Acrobat, and ability to collaborate with sponsors, vendors, and internal teams. Location: Remote (Slovakia).

Seeking a Senior/Principal Medical Writer to lead development of high-quality clinical study documents, ensure document lifecycle management with sponsors/vendors, perform QC and literature research, and contribute to SOPs/templates. Requires BS or equivalent in a scientific/medical discipline, proficiency with Microsoft Office/Adobe/Teams, and 5+ years (Sr. Medical Writer) or 7+ years (Principal) relevant experience; oncology/rare disease experience and advanced degrees are preferred. Candidates must be legally authorized to work in the country of employment without employer sponsorship.

The role leads development of high-quality clinical study documents from template to final approved version, collaborating with sponsors, vendors, and internal teams. Requires a BS (or equivalent) in a scientific/medical discipline, 5+ years' experience as a Senior Medical Writer (or 7+ as Principal), proficiency with Word/Excel/Teams/Adobe, knowledge of ICH/FDA/GCP, eCTD, and experience in oncology/rare disease preferred.