Senior Medical Writer / Principal Medical Writer

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Oversee the creation of high-quality clinical study documents delivered on schedule.

• Plan, draft, edit, format, and conduct quality control reviews of clinical documents, including study protocols, investigator brochures (IBs), informed consent form (ICF) templates, development safety update reports (DSURs), clinical study reports (CSRs), and CSR patient narratives.

• Generate documents in adherence to the Precision MW Style Guide, Precision SOPs, pertinent regulatory standards, and eCTD specifications.

• Ensure efficient document management from the template stage to the final approved version, collaborating with sponsors, external vendors, and internal Precision project teams and departments.

• Independently extract key messages from clinical study data.

• Write complex content utilizing relevant knowledge, skills, and understanding of processes.

• Communicate effectively and succinctly with both internal and client teams.

• Assist in the development and maintenance of medical writing processes, SOPs, templates, and work instructions.

• Conduct literature-based research to support writing tasks.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• Bachelor’s degree or equivalent in a scientific or medical field, along with relevant writing experience.

• Over 5 years of experience as a Senior Medical Writer in either a sponsor or CRO environment, or more than 7 years as a Principal Medical Writer.

• Proficient in Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.

• Strong understanding of applicable regulations, including ICH, FDA, and GCP.

• Knowledge of clinical trial transparency requirements, such as EudraCT and CT.gov.

• Familiarity with eCTD requirements across all development phases.

• Exceptional attention to detail with the capability to complete writing assignments promptly.

• Ability to thrive in a fast-paced setting with numerous high-priority projects, requiring minimal guidance for routine tasks and limited direction for new assignments.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits package.

• Opportunities for professional development and career advancement.

• Flexible working arrangements to support work-life balance.