Senior Manager, Medical & Scientific Writing

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

Job summary

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

You will ensure cross-project consistency in document standards, develop protocol frameworks, and collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance to deliver submission-ready, scientifically rigorous content.

Qualifications

• PhD with >3 years of relevant experience or a life sciences degree with 6–10 years medical/technical writing in biopharma.
• Ability to distill complex data into clear, accurate, impactful content.
• Experience collaborating with biostatistics, clinical, regulatory, manufacturing, and quality teams.

Responsibilities

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

Skills

Scientific writing

Cross-functional collaboration

Regulatory submissions

Biopharma knowledge

Ophthalmology knowledge

Education

PhD

Bachelor’s/Master’s degree in life sciences

Tools

Microsoft Word

PowerPoint

SharePoint

Templates governance

Job description

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

You will ensure cross-project consistency in document standards, develop protocol frameworks, and collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance to deliver submission-ready, scientifically rigorous content.