Director, Medical Writing

Scorpion Therapeutics; Wilmington (DE); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Lead Medical Writer to oversee global regulatory submissions and ensure high-quality, compliant clinical documents across biopharma programs. You will coordinate internal teams and external resources, manage timelines, and ensure adherence to ICH standards.

The role requires a decade of medical writing experience, deep regulatory knowledge, and strong project management skills.

Qualifications

• Bachelor's degree in a scientific/regulatory field.
• 10+ years of medical writing experience in biopharma/CRO.
• Deep understanding of global regulatory requirements and clinical data interpretation.
• Proven project management and cross-functional collaboration capabilities.

Responsibilities

• Oversee the development of regulatory documents such as IBs, CSRs, and marketing applications.
• Coordinate internal teams and external resources, managing timelines and quality.
• Serve as a subject matter expert on document types, processes, and SOPs; mentor writers if applicable.

Skills

Medical writing

Regulatory submissions

Project management

Education

Bachelor's degree

Advanced degree (preferred)

Job description

Role

Lead medical writing activities for global regulatory submissions within biopharma programs, ensuring accurate, compliant, and high-quality clinical documents.

Responsibilities

oversee the development of regulatory documents such as IBs, CSRs, and marketing applications, coordinating internal teams and external resources, managing timelines, and maintaining adherence to global standards like ICH. Serve as a subject matter expert on document types, processes, and best practices; contribute to process improvements and SOPs; mentor or manage writers if applicable.

Requirements

Bachelor's degree, 10+ years of medical writing experience in biopharma/CRO, deep understanding of clinical data interpretation, global regulatory requirements, and project management.

Preferred

advanced degree in a scientific/clinical/regulatory field, therapeutic area expertise across all phases, and prior management experience.

HighValue

extensive experience with global regulatory submissions, clinical development knowledge, and proficiency with electronic document management systems.

Collaboration/reporting

reports to a senior medical writing leader, possibly manages a team, participates in leadership and cross-functional initiatives.

WorkSetup

not specified, but role involves global regulatory document oversight.