Senior Medical Writer/Principal Medical Writer

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

📋 Description

• Oversee the creation of top-quality, timely clinical study documentation.

• Strategically plan, compose, edit, format, and conduct quality control reviews of clinical 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 that adhere to the Precision MW Style Guide, Precision Standard Operating Procedures (SOPs), International Conference on Harmonisation (ICH), Food and Drug Administration (FDA), Good Clinical Practice (GCP), and electronic Common Technical Document (eCTD) standards.

• Oversee the document lifecycle from template through to the final approved version in collaboration with sponsors, external vendors, and internal Precision project teams and departments.

• Independently distill key messages from clinical study data.

• Craft intricate content utilizing relevant expertise, skills, and process comprehension.

• Communicate effectively and succinctly with both internal and client teams, both in writing and verbally.

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

• Conduct literature-based research to aid writing tasks.

• Perform other assigned responsibilities as needed.

⛳️ Requirements

• Bachelor's degree or equivalent in a scientific or medical field with pertinent writing experience.

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

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

• Strong understanding of relevant regulations (e.g., ICH, FDA, GCP), clinical trial transparency obligations (EudraCT, CT.gov), and eCTD requirements across all development phases.

• Exceptional attention to detail and capability to complete writing tasks promptly.

• Ability to thrive in a dynamic environment with multiple high-priority projects, managing routine tasks independently and requiring minimal guidance on new assignments.

• Candidates must possess legal authorization to work in the country of employment without the need for employer sponsorship.

• An advanced degree (MS/PhD) is preferred.

• Experience in oncology and/or rare diseases is preferred.

🏝️ 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 work-from-home options.

• Supportive work environment with a focus on teamwork and collaboration.