Lead Medical Writer: Global Regulatory Submissions & Guidance

Syneos Health, Inc.; Morrisville (NC); On-site; USD 100,000 - 150,000; Full time

Job summary

Syneos Health, Inc. is seeking a medical writing professional to develop regulatory documents for global submissions and to lead projects in a fast-paced, CRO-like environment. You will coordinate timelines with study teams and ensure alignment with ICH-guideline standards while mentoring junior staff.

Join a team that partners across drug development and commercialization to accelerate patient progress. This role emphasizes quality, process improvement, and collaboration with cross-functional

Qualifications

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other guidelines.
• Manage medical writing projects, including timelines and cross-functional communications.
• Participate in cross-functional meetings to provide input on deliverables and processes.
• Review related documents and SOPs to ensure quality and compliance.
• Mentor junior medical writing staff and support resource planning.

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte 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) 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) (eg, 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, Inc. is seeking a medical writing professional to develop regulatory documents for global submissions and to lead projects in a fast-paced, CRO-like environment. You will coordinate timelines with study teams and ensure alignment with ICH-guideline standards while mentoring junior staff.

Join a team that partners across drug development and commercialization to accelerate patient progress. This role emphasizes quality, process improvement, and collaboration with cross-functional