Remote Sr Principal Medical Writer - Regulatory Submissions

Syneos Health, Inc.; Delaware; A distancia; USD 114.000 - 211.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Company car/allowance

Health benefits

401k match

Stock Purchase Plan

Bonus eligibility

Paid time off

Descripción de la vacante

Syneos Health, Inc. seeks a Sr. Principal Medical Writer to lead regulatory submission documents across global programs, including ICH-compliant materials (ISE/ISS/Clinical Overview). Remote role with major responsibilities for strategy, timelines, and cross-functional collaboration.

You will mentor junior writers, oversee multiple projects, and ensure high-quality, data-driven documents that meet regulatory standards. Oncology experience is preferred but not mandatory.

Formación

• Oncology experience preferred but not required.
• Bachelor's degree in a relevant field required; advanced degree preferred.
• Minimum 5 years of medical writing experience in biopharmaceutical/CRO.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational, time management, and project management skills.
• Proficient understanding of global regulatory requirements and therapeutic areas.
• Proficient with MS Word and EDMS/templates.

Responsabilidades

• Develop regulatory documents for global submission following ICH guidelines and client standards.
• Manage medical writing projects with timelines and cross-functional coordination.
• Participate in cross-functional meetings to align deliverables and timelines.
• Review related documents such as Protocols and SAPs for accuracy.
• Engage in process improvement initiatives and SOP development.
• Mentor junior medical writing staff and manage resources.

Conocimientos

Oncology experience

Regulatory writing

Project management

Educación

Bachelor's degree

Advanced degree

Herramientas

MS Word

Electronic document management system

Descripción del empleo

Syneos Health, Inc. seeks a Sr. Principal Medical Writer to lead regulatory submission documents across global programs, including ICH-compliant materials (ISE/ISS/Clinical Overview). Remote role with major responsibilities for strategy, timelines, and cross-functional collaboration.

You will mentor junior writers, oversee multiple projects, and ensure high-quality, data-driven documents that meet regulatory standards. Oncology experience is preferred but not mandatory.