Senior Medical Writer — Lead Complex Clinical Deliverables

Syneos Health; España; On-site; EUR 70,000 - 100,000; Full time

Job summary

Syneos Health in Spain is seeking a Principal Medical Writer / Sr Principal Medical Writer—Sponsor-dedicated. You will lead the completion of complex medical writing deliverables across studies, coordinating strategy and cross-department collaboration with minimal supervision.

The role requires 6+ years in medical writing, deep knowledge of FDA/ICH regulations, and experience across study documents. You will mentor junior writers and interact with clients to ensure high-quality scientific

Qualifications

• 6+ years of relevant experience in science, technical, or medical writing.
• Extensive experience working in the biopharmaceutical, device, or contract research organization industry.
• Advanced understanding of FDA and ICH regulations and guidelines and/or good publication practices.
• Extensive experience writing relevant document types.
• Extensive knowledge of English grammar and AMA Manual of Style.

Responsibilities

• Leads the clear and accurate completion of complex medical writing deliverables.
• Manages medical writing activities across studies with document strategy and cross‑department coordination.
• Adheres to regulatory standards, SOPs, templates, authorship requirements, and style guides.
• Advises clients and study teams on data presentation and production strategies.
• Leads team document reviews and coordinates quality and editorial reviews.
• Serves as expert peer reviewer for internal team and provides review comments.
• Reviews statistical analysis plans and table/figure/listing specifications for content and formatting.
• Interacts with clients, department heads, and team members across data management, biostatistics, regulatory affairs, and medical affairs.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions, escalates issues, and contributes to internal materials and processes.
• Mentors and leads less experienced medical writers on complex documents.
• Develops deep expertise on regulatory requirements and engages with industry groups.
• Aware of budget specifications and contributes to bid projections.
• Communicates status and negotiates timelines with leadership.
• Represents the medical writing department on clinical study teams and at conferences.
• Completes required administrative tasks within timeframes.
• Performs other duties; travel may be up to 25%.

Skills

Medical writing

Leadership

Client communication

Regulatory knowledge

Mentoring

Job description

Syneos Health in Spain is seeking a Principal Medical Writer / Sr Principal Medical Writer—Sponsor-dedicated. You will lead the completion of complex medical writing deliverables across studies, coordinating strategy and cross-department collaboration with minimal supervision.

The role requires 6+ years in medical writing, deep knowledge of FDA/ICH regulations, and experience across study documents. You will mentor junior writers and interact with clients to ensure high-quality scientific