Senior Medical Writing Director

Comunidade Metodista; Delaware (OH); On-site; USD 150,000 - 210,000; Full time

Job summary

Incyte Corporation in Delaware, OH seeks an Associate Director/Director of Medical Writing to lead regulatory documents for global submissions. You will oversee internal and external writers, ensure timely, high-quality data presentation, and work with regulatory staff to strategize submissions.

The role requires deep regulatory knowledge, 10+ years in medical writing, and strong leadership to guide teams and processes across programs.

Qualifications

• Bachelor's degree required; advanced degree preferred in scientific/clinical/regulatory fields.
• 10+ years of medical writing experience in biopharma/CRO industries.
• Ability to interpret clinical data and present clear data messages.
• Strong project management skills and understanding of timelines and interdependencies.
• Excellent communication skills and collaboration with cross-functional teams.
• Knowledge of global regulatory requirements and therapeutic areas.

Responsibilities

• Develop regulatory documents for global submission per ICH and internal standards.
• Lead and coordinate internal and external medical writing activities for regulatory submissions.
• Participate in cross-functional meetings to align deliverables and timelines.
• Lead process improvements and serve as subject matter expert for documents and tools.
• Help define SOPs and best practices for efficient document preparation.
• Oversee contract writers and scopes of work as needed.
• Provide mentoring and development for team members when applicable.
• Contribute to Medical Writing Leadership Team strategy.

Skills

Medical writing

Regulatory documents

Project management

Global regulatory requirements

Leadership / mentoring

Education

Bachelor's degree

Advanced degree in relevant field

Tools

MS Word

Document management systems

Job description

Incyte Corporation in Delaware, OH seeks an Associate Director/Director of Medical Writing to lead regulatory documents for global submissions. You will oversee internal and external writers, ensure timely, high-quality data presentation, and work with regulatory staff to strategize submissions.

The role requires deep regulatory knowledge, 10+ years in medical writing, and strong leadership to guide teams and processes across programs.