Senior Principal Medical Writer – Regulatory Submissions Lead

Syneos Health, Inc.; Polska; In loco; PLN 250.000 - 400.000; Tempo pieno

Descrizione del lavoro

Syneos Health, Inc. is seeking a Senior Principal Medical Writer to develop regulatory documentation for global submissions, applying ICH guidelines and client standards. The role involves managing writing projects, timelines, and cross-functional collaboration to ensure timely delivery.

Requirements include 5+ years of medical writing experience in biopharma/CRO, strong communication, and knowledge of global regulatory requirements. Oncology exposure is preferred but not mandatory.

Competenze

• Oncology experience preferred, but not required.
• Minimum five years of medical writing in biopharmaceuticals or CROs.
• Strong ability to organize and communicate clinical information with minimal oversight.
• Proficiency in global regulatory requirements and medical writing templates.

Mansioni

• Develop regulatory documents for global submissions in line with timelines.
• Manage medical writing projects and coordinate with cross-functional teams.
• Participate in cross-functional meetings to align on deliverables and reviews.
• Review related documents (Protocols, SAPs) as appropriate.
• Help define SOPs and best practices for efficient document preparation.
• Oversee internal and contract medical writing resources; mentor junior staff.

Conoscenze

Regulatory writing

Project management

Communication

Time management

Team collaboration

Formazione

Bachelor's degree

Advanced degree in scientific/regulatory field

Strumenti

MS Word

Electronic document management system

Descrizione del lavoro

Syneos Health, Inc. is seeking a Senior Principal Medical Writer to develop regulatory documentation for global submissions, applying ICH guidelines and client standards. The role involves managing writing projects, timelines, and cross-functional collaboration to ensure timely delivery.

Requirements include 5+ years of medical writing experience in biopharma/CRO, strong communication, and knowledge of global regulatory requirements. Oncology exposure is preferred but not mandatory.