Senior Manager, Medical Writing

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

Senior Manager in Global Regulatory Medical Writing

Role: Senior Manager in Global Regulatory Medical Writing responsible for preparing and editing complex clinical regulatory documents for drug submissions, including study reports, protocols, and investigator’s brochures. The position involves providing oversight, guidance, and resource management for medical writing activities at a project level. Responsibilities include ensuring document accuracy, regulatory compliance, and clear scientific messaging, as well as supporting process improvements and mentoring other writers. Qualifications: Bachelor's degree in life sciences or related field; 8+ years of relevant experience in clinical regulatory writing, with mastery of Microsoft Word and familiarity with electronic systems like Veeva Vault. Preferred: advanced degrees (Master’s, PhD, MD, PharmD). High-Value: experience with global regulatory guidelines, multiple therapeutic areas, and complex documentation standards. Industry-specific knowledge includes familiarity with drug development stages and regulatory submission requirements. Collaborates with cross-functional teams to deliver high-quality documentation aligned with regulatory timelines. Work setup is not explicitly specified. Travel requirements are not mentioned.