Senior Medical Writer — Remote (Protocols, CSRs & IBs)

Syneos Health, Inc.; España; A distancia; EUR 71.000 - 155.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Company car or car allowance

Company match 401k

Stock Purchase Plan

Commissions/bonus

Flexible PTO and sick time

Descripción de la vacante

Syneos Health is seeking a Senior Medical Writer with extensive clinical document writing experience (Protocols, CSRs and IBs) for a Functional Service Provider role. This remote opportunity supports global projects from Spain time zones.

You will lead medical writing deliverables, coordinate reviews, and ensure regulatory compliance per ICH guidelines while mentoring junior writers.

We offer competitive compensation and a benefits package aligned with industry standards.

Responsabilidades

• Leads the clear and accurate completion of medical writing deliverables for studies, coordinating activities within and across departments with minimal supervision.
• Produces documents including protocols, CSRs, IBs, amendments, annual reports, and submissions per regulatory standards.
• Adheres to ICH E3 guidelines and SOPs, ensuring on-time, on-budget delivery.
• Coordinates quality and editorial reviews; manages source documentation and reviews documents as needed.
• Acts as peer reviewer to ensure clarity, consistency, and proper formatting of documents.
• Reviews statistical analysis plans and tables/figures for content, grammar, and consistency; provides feedback on outputs.
• Interacts with clients, data management, biostatistics, regulatory affairs, and medical affairs to deliver writing deliverables.
• Performs online literature searches and complies with copyright requirements.
• Mentors and leads less experienced writers on complex projects; develops topic expertise and regulatory knowledge.
• Manages budgeted hours and communicates status to medical writing leadership; performs admin tasks and may travel up to 25%.

Descripción del empleo

Syneos Health is seeking a Senior Medical Writer with extensive clinical document writing experience (Protocols, CSRs and IBs) for a Functional Service Provider role. This remote opportunity supports global projects from Spain time zones.

You will lead medical writing deliverables, coordinate reviews, and ensure regulatory compliance per ICH guidelines while mentoring junior writers.

We offer competitive compensation and a benefits package aligned with industry standards.