Senior Manager, Scientific Writing — Regulatory Submissions

BioSpace; Malvern (Chester County); On-site; USD 120,000 - 180,000; Full time

Job summary

Ocugen seeks a Manager, Scientific/ Medical & Scientific Writing to lead planning, authoring, review and finalization of regulatory documents across development programs, ensuring clarity, accuracy and strategic alignment.

The role standardizes document standards and collaborates with Clinical Operations, Regulatory, Biostatistics, Data Management and Pharmacovigilance to deliver submission-ready content, supporting strategic messaging and cross-functional integration throughout the lifecycle.

Qualifications

• PhD with >3 years of relevant experience in biopharma writing.
• Distill complex data into clear, accurate, impactful content.
• Collaborate with cross-functional teams: biostatistics, clinical, regulatory, manufacturing, quality.

Responsibilities

• Author, analyze, and integrate technical data into regulatory documents (INDs, BLAs, DSURs, IMPDs).
• Collaborate with Regulatory Affairs for submissions (ODD, DSUR, RMAT).
• Perform quality control and editorial reviews to ensure accuracy and clarity.

Skills

Scientific writing

Cross-functional collaboration

Regulatory submissions

Editorial quality control

Document management

Education

PhD with >3 years experience

Bachelors/Master in life sciences with 6–10 years writing experience

Tools

Microsoft Word

PowerPoint

SharePoint

AI tools

Job description

Ocugen seeks a Manager, Scientific/ Medical & Scientific Writing to lead planning, authoring, review and finalization of regulatory documents across development programs, ensuring clarity, accuracy and strategic alignment.

The role standardizes document standards and collaborates with Clinical Operations, Regulatory, Biostatistics, Data Management and Pharmacovigilance to deliver submission-ready content, supporting strategic messaging and cross-functional integration throughout the lifecycle.