Senior Medical Writer, Early Phase — Single Sponsor

Visa Hunt; España; On-site; PHP 5,643,000 - 8,150,000; Full time

Job summary

Syneos Health is seeking a Senior Medical Writer in Early Phase, focusing on single sponsor support. You will lead medical writing deliverables across studies, coordinate complex documents, and ensure adherence to ICH/EU/FDA guidelines with high quality and timely delivery.

The role requires 3-5 years in regulatory writing, strong English grammar, and experience in biopharma or CRO environments; mentoring and client communication are also key aspects of the position.

Qualifications

• 3-5 years of relevant experience in regulatory writing.
• Experience in the biopharmaceutical, device, or CRO industry.
• Strong understanding of EMA, FDA and ICH regulations and good publication practices.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables for single sponsor studies.
• Coordinates references, source documents, and quality reviews with minimal supervision.
• Ensures regulatory standards and templates are followed on time and on budget.
• Interacts with clients and internal teams to resolve comments and questions.
• Mentors junior writers and contributes to internal materials and process improvements.
• Performs literature searches and complies with copyright requirements.

Skills

Regulatory writing

English grammar

Industry knowledge

Job description

Syneos Health is seeking a Senior Medical Writer in Early Phase, focusing on single sponsor support. You will lead medical writing deliverables across studies, coordinate complex documents, and ensure adherence to ICH/EU/FDA guidelines with high quality and timely delivery.

The role requires 3-5 years in regulatory writing, strong English grammar, and experience in biopharma or CRO environments; mentoring and client communication are also key aspects of the position.