Lead Medical & Regulatory Writing Manager

BioSpace; Malvern (Chester County); On-site; USD 120,000 - 170,000; Full time

Job summary

Ocugen is seeking a Manager of Scientific/Medical & Scientific Writing to lead planning, authoring, review, and finalization of regulatory documents across development programs. You will ensure accuracy, consistency, and strategic alignment in submissions supporting clinical development efforts.

Collaborating with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance, you will deliver submission-ready, scientifically rigorous content and contribute to

Qualifications

• PhD with >3 years relevant experience, or a Bachelor’s/Master’s degree in life sciences with 6-10 years of medical or technical writing experience in biopharmaceuticals.
• Demonstrated excellence in scientific writing, distilling complex data into clear, accurate content.
• Proven experience collaborating with cross-functional teams including biostatistics, clinical, regulatory, manufacturing, and quality.
• Strong understanding of regulatory submission processes and BLA submissions.
• Experience with biologics and/or gene therapy preferred; ophthalmology or neuroscience knowledge a plus.

Responsibilities

• Author, analyze, and integrate data into regulatory documents (CMC, toxicology, preclinical) for INDs, BLAs, DSURs, and IMPDs.
• Partner with Regulatory Affairs to support submissions (ODD, DSUR, RMAT).
• Perform quality control and editorial review for accuracy, consistency, structure, and clarity.
• Support responses to regulatory agency queries and information requests.
• Manage document review workflows and approvals for timely submissions.
• Develop scientific presentations, manuscripts, clinical study reports, abstracts and publications.
• Develop and maintain protocols and guidance documents for clinical and research activities.
• Drive timelines and coordinate with cross-functional stakeholders for on-time delivery.
• Translate complex scientific data into clear communications for diverse audiences.

Skills

Scientific writing

Cross-functional collaboration

Editorial quality control

Regulatory submissions

Microsoft Office

SharePoint

AI tools familiarity

Education

PhD

Bachelor’s/Master’s in life sciences

Tools

Microsoft Word

PowerPoint

SharePoint

Illustration tools

AI tools/platforms

Job description

Ocugen is seeking a Manager of Scientific/Medical & Scientific Writing to lead planning, authoring, review, and finalization of regulatory documents across development programs. You will ensure accuracy, consistency, and strategic alignment in submissions supporting clinical development efforts.

Collaborating with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance, you will deliver submission-ready, scientifically rigorous content and contribute to