Principal Medical Writer. Spain. FSP. Remote.

📋 Description

• • Develop regulatory clinical documents for global submissions to health authorities, ensuring full compliance with ICH guidelines, client authoring standards, and corporate objectives.
• • Serve as lead writer for key regulatory documents including Investigators’ Brochures (IBs), Clinical Study Reports (CSRs), and marketing authorization submissions.
• • Provide strategic direction and oversight to cross-functional project teams with minimal supervision to ensure accurate, consistent, and scientifically rigorous presentation of clinical data.
• • Manage multiple medical writing projects simultaneously, developing and maintaining project timelines in alignment with study and regulatory deadlines.
• • Coordinate with cross-functional teams including clinical operations, biostatistics, and regulatory affairs to align document deliverables with project milestones and review cycles.
• • Review and provide input on related study documents such as protocols and statistical analysis plans to ensure data integrity and consistency across submissions.
• • Lead and mentor junior medical writers, providing guidance on writing standards, regulatory expectations, and therapeutic area knowledge.
• • Oversee internal and contract medical writing resources to ensure timely, high-quality delivery of all assigned documents.
• • Participate in process improvement initiatives to enhance efficiency and quality of medical writing workflows.
• • Contribute to the development and refinement of standard operating procedures (SOPs) and best practices for regulatory document preparation.
• • Maintain a broad understanding of clinical research processes and global regulatory requirements across all phases of drug development.
• • Utilize MS Word and electronic document management systems with templates to produce, track, and manage documents in compliance with corporate and client standards.
• • Ensure all documents are logically organized, accurately interpreted, and free of scientific or grammatical errors prior to submission.
• • Act as a subject matter expert in medical writing for assigned therapeutic areas and compounds, advising teams on regulatory documentation strategy.
• • Represent the medical writing function in cross-functional meetings to communicate timelines, risks, and resource needs for regulatory deliverables.
• • Maintain awareness of evolving global regulatory guidance and incorporate updates into document development practices.
• • Support company-wide initiatives to foster an inclusive, collaborative culture aligned with Syneos Health’s purpose of driving patient progress.