Senior Medical Writing Lead (Remote)

Incyte Corporation; Wilmington (DE); Remote; USD 140,000 - 190,000; Full time

Job summary

Incyte Corporation is seeking an Associate Director, Principal Medical Writer II to lead the development of clinical regulatory documents for global submissions. You will guide cross‑functional teams, ensure data accuracy, and maintain scientifically rigorous narratives across IBs, CSRs, and submission documents.

This remote role requires strong writing, regulatory knowledge, and mentoring capabilities to advance multiple programs while aligning with ICH guidelines and company standards.

Qualifications

• Bachelor's degree or equivalent required; advanced degree preferred.
• Strong verbal, written, and interpersonal communication skills.
• Proficient in MS Word; experience with an EDMS and templates.
• Knowledge of global regulatory requirements and therapeutic areas.
• Excellent project management and understanding of clinical timelines.

Responsibilities

• Lead development and oversight of clinical regulatory documents for global submissions.
• Provide strategic direction to cross-functional teams with minimal oversight.
• Mentor writers and ensure timely delivery of high-quality documents.
• Review and coordinate documents across protocols and submission packages.
• Lead or coordinate internal and external medical writing activities for applications.
• Develop regulatory documents per ICH and company standards within timelines.

Skills

Strong communication

Project management

Cross-functional collaboration

Regulatory writing knowledge

Problem solving

Education

Bachelor's degree or equivalent

Advanced degree preferred

Tools

MS Word

Electronic Document Management System

Job description

Incyte Corporation is seeking an Associate Director, Principal Medical Writer II to lead the development of clinical regulatory documents for global submissions. You will guide cross‑functional teams, ensure data accuracy, and maintain scientifically rigorous narratives across IBs, CSRs, and submission documents.

This remote role requires strong writing, regulatory knowledge, and mentoring capabilities to advance multiple programs while aligning with ICH guidelines and company standards.