Manager/ Sr Manager, Medical & Scientific Writing
Ocugen
August 11, 2026
On-site
Malvern, PA
Medical Affairs
Responsibilities:
- Author, analyze, and integrate technical data (CMC, nonclinical toxicology, and preclinical efficacy) into regulatory documents (Pre-INDs, INDs, BLAs, DSURs, IMPDs).
- Partner with Regulatory Affairs to prepare/support submissions (ODD, DSUR, RMAT requests) using preclinical data and disease prevalence insights.
- 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 approval processes to ensure timely submissions.
- Contribute to scientific presentations, manuscripts, clinical study reports, programs, abstracts, and publications.
- Develop and maintain detailed protocols and guidance documents for clinical/research activities.
- Drive timelines and coordinate with cross-functional stakeholders for on-time delivery.
- Translate complex scientific/clinical data into clear, concise communications for diverse audiences.
Qualifications:
- PhD with >3 years relevant experience, or Bachelor’s/Master’s in life sciences with 6–10 years medical/technical writing experience in biopharma.
- Demonstrated excellence in scientific writing.
- Proven cross-functional collaboration (biostatistics, clinical, regulatory, manufacturing, quality).
- Strong scientific principles, research methodologies, and global regulatory knowledge.
- Preferred: experience with biologics and/or gene therapy; plus knowledge of ophthalmology or neuroscience.
- In-depth drug development lifecycle and regulatory submission processes, including BLA submissions.
- Proficient in Microsoft Office (Word, PowerPoint) and collaborative authoring platforms (e.g., SharePoint, structured templates).
- Familiarity with illustration/visualization tools; AI tools/platforms are a plus.
- Author, analyze, and integrate technical data (CMC, nonclinical toxicology, and preclinical efficacy) into regulatory documents (Pre-INDs, INDs, BLAs, DSURs, IMPDs).
- Partner with Regulatory Affairs to prepare/support submissions (ODD, DSUR, RMAT requests) using preclinical data and disease prevalence insights.
- 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 approval processes to ensure timely submissions.
- Contribute to scientific presentations, manuscripts, clinical study reports, programs, abstracts, and publications.
- Develop and maintain detailed protocols and guidance documents for clinical/research activities.
- Drive timelines and coordinate with cross-functional stakeholders for on-time delivery.
- Translate complex scientific/clinical data into clear, concise communications for diverse audiences.
Qualifications:
- PhD with >3 years relevant experience, or Bachelor’s/Master’s in life sciences with 6–10 years medical/technical writing experience in biopharma.
- Demonstrated excellence in scientific writing.
- Proven cross-functional collaboration (biostatistics, clinical, regulatory, manufacturing, quality).
- Strong scientific principles, research methodologies, and global regulatory knowledge.
- Preferred: experience with biologics and/or gene therapy; plus knowledge of ophthalmology or neuroscience.
- In-depth drug development lifecycle and regulatory submission processes, including BLA submissions.
- Proficient in Microsoft Office (Word, PowerPoint) and collaborative authoring platforms (e.g., SharePoint, structured templates).
- Familiarity with illustration/visualization tools; AI tools/platforms are a plus.