Senior Medical Writer – Regulatory & Clinical Lead

Syneos Health, Inc.; España; On-site; EUR 60,000 - 90,000; Full time

Job summary

Syneos Health is seeking a Sr Medical Writer to lead sponsor-dedicated medical writing activities across UK, Poland, Spain, and Serbia. You will ensure accurate, regulation-compliant deliverables and coordinate across departments to meet client timelines.

The role emphasizes strong English language skills, familiarity with AMA style, and experience producing diverse document types from protocols to journal manuscripts. Occasional travel may be involved as projects require.

Qualifications

• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry required.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
• Experience writing relevant document types required.
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, coordinating activities across departments with minimal supervision.
• Completes documents such as protocols, clinical study reports, patient narratives, investigator brochures, informed consents, and journal manuscripts.
• Adheres to regulatory standards and templates, ensuring on-time and on-budget delivery.
• Coordinates quality and editorial reviews and leads team document reviews.
• Acts as peer reviewer to ensure scientific content, clarity, and proper format.

Skills

Medical writing

Regulatory understanding

Excellent English

Communication skills

Job description

Syneos Health is seeking a Sr Medical Writer to lead sponsor-dedicated medical writing activities across UK, Poland, Spain, and Serbia. You will ensure accurate, regulation-compliant deliverables and coordinate across departments to meet client timelines.

The role emphasizes strong English language skills, familiarity with AMA style, and experience producing diverse document types from protocols to journal manuscripts. Occasional travel may be involved as projects require.