Principal Medical Writer — Regulatory Submissions Lead

サイネオス・ヘルス; Polska; Hybrid; PLN 260,000 - 380,000; Full time

Job summary

Syneos Health is seeking a Principal / Sr Principal Medical Writer (Regulatory Submission) to drive the creation of regulatory documents for global submissions in line with ICH guidelines and company standards. The role emphasizes timely delivery within study/project timelines and collaboration with cross-functional teams.

You will manage medical writing projects, oversee timelines, and mentor junior writers while contributing to process improvements and SOP development to ensure high-quality

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and internal authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.
• Participate in cross-functional process improvement initiatives.
• Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
• Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

Job description

Syneos Health is seeking a Principal / Sr Principal Medical Writer (Regulatory Submission) to drive the creation of regulatory documents for global submissions in line with ICH guidelines and company standards. The role emphasizes timely delivery within study/project timelines and collaboration with cross-functional teams.

You will manage medical writing projects, oversee timelines, and mentor junior writers while contributing to process improvements and SOP development to ensure high-quality