Senior Medical Writer / Principal Medical Writer

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

📋 Description

• Oversee the creation of high-quality clinical study documents, ensuring timely delivery.

• Plan, write, edit, format, and conduct quality control reviews of clinical documents, including clinical study protocols, Investigator's Brochures (IBs), Informed Consent Form (ICF) templates, Development Safety Update Reports (DSURs), Clinical Study Reports (CSRs), and CSR patient narratives.

• Prepare documents in alignment with the Precision MW Style Guide, Precision Standard Operating Procedures (SOPs), relevant regulatory guidelines (ICH, FDA, GCP), and electronic Common Technical Document (eCTD) requirements.

• Manage documents from initial template creation to the final approved version, collaborating with sponsors, external vendors, and internal Precision project teams and departments.

• Independently derive key messages from clinical study data.

• Author intricate content utilizing knowledge, skills, and an 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.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

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

• A minimum of 5 years of experience as a Senior Medical Writer in a sponsor and/or Contract Research Organization (CRO) environment, or over 7 years as a Principal Medical Writer.

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

• Thorough understanding of applicable regulations (e.g., ICH, FDA, GCP), clinical trial transparency mandates (i.e., EudraCT, CT.gov), and eCTD requirements across all development phases.

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

• Ability to thrive in a fast-paced environment, managing multiple high-priority projects with minimal guidance on routine tasks and limited direction on new assignments.

• Candidates must have legal authorization to work in the country of employment without requiring employer sponsorship.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits including medical, dental, and vision coverage.

• Opportunities for professional development and continuing education.

• Flexible working hours and the possibility of remote work.

• A supportive and collaborative work environment.