Principal Medical Writer

Scorpion Therapeutics; United States; Remote; USD 90,000 - 140,000; Full time

Benefits offered by this job

Remote work

Occasional travel

Job summary

Scorpion Therapeutics is seeking a scientific writer specializing in clinical and regulatory documents to support biotech product development. You will develop and manage high-quality protocols, IBs, clinical reports, and regulatory submissions, ensuring compliance with regulations and internal standards.

The role includes mentoring junior staff, leading document project timelines, identifying risks, and collaborating with study and program teams. Primarily remote with occasional travel.

Qualifications

• Advanced degree in life sciences (MS/PhD/PharmD/MD) required.
• 4+ years regulatory writing experience for MS; 2+ years for PhD/MD.
• Experience with regulatory submissions is preferred.
• Strong project management and collaboration skills.

Responsibilities

• develop and manage high-quality documents (protocols, IBs, clinical reports, regulatory submissions) ensuring compliance with regulations and internal standards
• mentor junior staff
• lead document project timelines, identify risks, and collaborate with study and program teams
• optimize processes and tools
• contribute to training and knowledge sharing within the department

Skills

Regulatory writing

Project management

Cross-functional collaboration

Mentoring

Process improvement

Education

MS/PhD/PharmD/MD in life sciences

Tools

Microsoft Word

Adobe Acrobat

Document management systems

Job description

Role

Scientific writer specializing in clinical and regulatory documents to support biotech product development.

Responsibilities

• develop and manage high-quality documents (protocols, IBs, clinical reports, regulatory submissions) ensuring compliance with regulations and internal standards
• mentor junior staff
• lead document project timelines, identify risks, and collaborate with study and program teams
• optimize processes and tools
• contribute to training and knowledge sharing within the department

Requirements

• advanced degree (MS/PhD/PharmD/MD) in life sciences
• 4+ years (MS) or 2+ years (PhD/MD) regulatory writing experience
• proficiency in Microsoft Word, Adobe Acrobat, and document management systems
• strong project management and cross-functional collaboration skills

High Value

• experience with global regulatory submissions (INDs, NDAs, BLAs, MAAs)
• focus on cancer therapeutics
• ability to manage complex, multi-document projects
• occasional travel

Work Setup

primarily remote with occasional travel.