Manager/ Sr Manager, Medical & Scientific Writing
Ocugen
9 days ago
On-site
Malvern, PA
Medical Affairs
Position Summary
- Ensure clarity, accuracy, and strategic alignment of clinical and regulatory documentation across development programs; plan, author, review, and finalize high-quality documents.
- Establish cross-project consistency in document standards (protocol frameworks and standardized case report form modules).
- Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance to deliver scientifically rigorous, submission-ready content.
Responsibilities
- Author, analyze, and integrate CMC, nonclinical toxicology, and preclinical efficacy into regulatory documents (Pre-INDs, INDs, BLAs, DSURs, IMPDs).
- Partner with Regulatory Affairs on submissions including Orphan Drug Designation (ODD), DSUR, and RMAT requests using preclinical data and disease prevalence insights.
- Perform quality control/editorial review for accuracy, consistency, structure, and clarity.
- Support responses to regulatory agency queries and information requests.
- Manage document review workflows and approval processes for timely regulatory submissions.
- Contribute to scientific presentations, manuscripts, clinical study reports, abstracts/publications.
- Develop/maintain protocols and guidance for clinical/research activities.
- Drive timelines and coordinate cross-functional stakeholders.
- 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.
- Excellence in scientific writing; distill complex data into clear, accurate content.
- Experience collaborating cross-functionally (biostatistics, clinical, regulatory, manufacturing, quality).
- Strong knowledge of scientific principles, research methods, and global regulatory requirements.
- Preferred: biologics and/or gene therapy; plus: ophthalmology or neuroscience.
- In-depth knowledge of drug development lifecycle, regulatory submissions, and BLA submissions.
- Proficient in Microsoft Office (Word, PowerPoint) and collaborative authoring platforms (e.g., SharePoint, structured templates).
- Plus: illustration/visualization tools and familiarity with AI tools/platforms.
Working Conditions
- In-office, in person; may require availability outside standard hours for priority needs.
- Ensure clarity, accuracy, and strategic alignment of clinical and regulatory documentation across development programs; plan, author, review, and finalize high-quality documents.
- Establish cross-project consistency in document standards (protocol frameworks and standardized case report form modules).
- Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance to deliver scientifically rigorous, submission-ready content.
Responsibilities
- Author, analyze, and integrate CMC, nonclinical toxicology, and preclinical efficacy into regulatory documents (Pre-INDs, INDs, BLAs, DSURs, IMPDs).
- Partner with Regulatory Affairs on submissions including Orphan Drug Designation (ODD), DSUR, and RMAT requests using preclinical data and disease prevalence insights.
- Perform quality control/editorial review for accuracy, consistency, structure, and clarity.
- Support responses to regulatory agency queries and information requests.
- Manage document review workflows and approval processes for timely regulatory submissions.
- Contribute to scientific presentations, manuscripts, clinical study reports, abstracts/publications.
- Develop/maintain protocols and guidance for clinical/research activities.
- Drive timelines and coordinate cross-functional stakeholders.
- 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.
- Excellence in scientific writing; distill complex data into clear, accurate content.
- Experience collaborating cross-functionally (biostatistics, clinical, regulatory, manufacturing, quality).
- Strong knowledge of scientific principles, research methods, and global regulatory requirements.
- Preferred: biologics and/or gene therapy; plus: ophthalmology or neuroscience.
- In-depth knowledge of drug development lifecycle, regulatory submissions, and BLA submissions.
- Proficient in Microsoft Office (Word, PowerPoint) and collaborative authoring platforms (e.g., SharePoint, structured templates).
- Plus: illustration/visualization tools and familiarity with AI tools/platforms.
Working Conditions
- In-office, in person; may require availability outside standard hours for priority needs.