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

📋 Description

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

• Strategically plan, compose, edit, format, and conduct quality control reviews of 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.

• Create documents that adhere to the Precision MW Style Guide, Precision Standard Operating Procedures (SOPs), ICH, FDA, GCP, and eCTD standards.

• Manage documents from the template stage to the final approved version in partnership with sponsors, external vendors, and internal Precision teams/departments.

• Independently derive key messages from clinical study data.

• Craft complex content utilizing expertise, skills, and an understanding of processes.

• Communicate effectively and succinctly with internal teams and clients.

• Contribute to the development 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, accompanied by relevant writing experience.

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

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

• Comprehensive understanding of relevant regulations (such as ICH, FDA, GCP), clinical trial transparency requirements (EudraCT, CT.gov), and eCTD requirements across all development phases.

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

• Capacity to perform effectively in a fast-paced environment with multiple high-priority projects, requiring minimal guidance for routine work and limited instruction for new tasks.

• Advanced degree (MS/PhD) is preferred.

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