Manager/ Sr Manager, Medical & Scientific Writing

Role: Senior Manager of Scientific/Medical & Scientific Writing responsible for developing and ensuring the accuracy, clarity, and strategic consistency of clinical and regulatory documentation supporting Ocugen’s development programs. Responsibilities: authoring, reviewing, and integrating scientific data into documents such as Pre-INDs, INDs, BLAs, DSURs, and IMPDs; supporting regulatory submissions including Orphan Drug Designation, DSUR, and RMAT requests; managing document quality control, workflows, and responses to agency inquiries; and contributing to scientific publications and presentation materials. Qualifications: PhD with over 3 years or a Bachelor’s/Master’s with 6–10 years in biopharma technical writing; proven ability to distill complex scientific data; experience collaborating across functions like clinical, regulatory, biostatistics, and manufacturing; strong understanding of drug development, especially biologics or gene therapies, with knowledge of ophthalmology or neuroscience being advantageous. HighValue: biologics/gene therapy, clinical development lifecycle, regulatory submission processes, cross-functional collaboration, global regulatory standards. WorkSetup: in-office, with possible outside hours for business needs.