Global Regulatory Medical Writing Leader

Teva Pharmaceuticals; West Chester (Chester County); On-site; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Manager in Global Regulatory Medical Writing to lead the preparation and editing of complex clinical regulatory documents for drug submissions, including study reports, protocols, and investigator’s brochures.

The role involves providing project-level oversight, ensuring regulatory compliance, and mentoring other writers. Advanced degrees are preferred, and experience with global guidelines across multiple therapeutic areas is highly valued.

Qualifications

• Bachelor's degree in life sciences or related field required.
• 8+ years of clinical regulatory writing experience.
• Expertise in Microsoft Word; familiarity with Veeva Vault.
• Experience with global regulatory guidelines and multiple therapeutic areas is a plus.

Responsibilities

• Prepare and edit complex clinical regulatory documents for drug submissions (e.g., study reports, protocols, Investigator's brochures).
• Provide oversight, guidance, and resource management for medical writing at the project level.
• Ensure document accuracy, regulatory compliance, and clear scientific messaging.
• Mentor other writers and drive process improvements; collaborate with cross-functional teams.

Skills

Regulatory medical writing

Project oversight

Mentoring writers

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Advanced degree (Master's/PhD/MD/PharmD)

Tools

Microsoft Word

Veeva Vault

Job description

Scorpion Therapeutics seeks a Senior Manager in Global Regulatory Medical Writing to lead the preparation and editing of complex clinical regulatory documents for drug submissions, including study reports, protocols, and investigator’s brochures.

The role involves providing project-level oversight, ensuring regulatory compliance, and mentoring other writers. Advanced degrees are preferred, and experience with global guidelines across multiple therapeutic areas is highly valued.