Lead Scientific & Medical Writing for Regulatory Submissions

Ocugen Opco Inc; Malvern (AR); On-site; USD 110,000 - 180,000; Full time

Job summary

Ocugen Opco Inc. seeks a Manager, Scientific/Medical & Scientific Writing to lead and contribute to planning, authoring, review, and finalization of regulatory documents across development programs.

You will ensure cross-project consistency in document standards and support submissions with scientifically rigorous content. Responsibilities include coordinating with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance, and translating complex data into

Qualifications

• Author, analyze, and integrate technical data into regulatory documents (INDs, DSURs, BLAs).
• Lead editorial reviews to ensure accuracy, clarity, and consistency across documents.
• Collaborate with Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance.

Responsibilities

• Prepare and finalize regulatory documents (e.g., protocol frameworks, CRMs).
• Translate complex data into clear, structured communications for diverse audiences.
• Support regulatory submissions and agency inquiries and responses.
• Drive document review workflows and cross-functional alignment."
• Contribute to scientific presentations, manuscripts, and publications.

Skills

Regulatory Writing

Scientific Writing

Cross-functional collaboration

Editorial QC

Process Improvement

Education

PhD in life sciences

Bachelor's/Master’s in life sciences

Tools

Microsoft Word

PowerPoint

SharePoint

Job description

Ocugen Opco Inc. seeks a Manager, Scientific/Medical & Scientific Writing to lead and contribute to planning, authoring, review, and finalization of regulatory documents across development programs.

You will ensure cross-project consistency in document standards and support submissions with scientifically rigorous content. Responsibilities include coordinating with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance, and translating complex data into