Position Summary
The Manager, Scientific/ Medical & Scientific Writing plays a critical role in ensuring the clarity, accuracy, and strategic alignment of clinical and regulatory documentation across development programs. This individual will lead and contribute to the planning, authoring, review, and finalization of high-quality documents supporting Ocugen’s clinical development efforts.
This role is responsible for establishing cross-project consistency in document standards, including the development of protocol frameworks and standardized case report form modules. The Senior Manager will collaborate closely with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance to deliver submission-ready content that is scientifically rigorous and aligned across functions. In addition to execution, this position will support strategic messaging, document quality, and cross-functional integration throughout the clinical development lifecycle.
Responsibilities
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Author, analyze, and integrate technical data (CMC, nonclinical toxicology, and preclinical efficacy) into regulatory documents, including Pre-INDs, INDs, BLAs, DSURs, and IMPDs.
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Partner with Regulatory Affairs to prepare and support submissions such as Orphan Drug Designation (ODD), DSUR and RMAT requests, leveraging preclinical data and disease prevalence insights.
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Perform quality control and editorial review to ensure documents meet standards for accuracy, consistency, structure, and clarity.
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Support responses to regulatory agency queries and information requests.
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Manage document review workflows and approval processes to ensure timely regulatory submissions.
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Contributes to the development of scientific presentations, manuscripts, clinical study reports, clinical development programs, abstracts and publications.
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Develop and maintain detailed protocols and guidance documents for clinical and research activities including support with corporate and scientific presentations.
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Drive timelines and coordinate with cross-functional stakeholders to ensure on-time delivery of documents.
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Translate complex scientific and clinical data into clear, concise, and well-structured communications for diverse audiences.
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PhD with >3 years of relevant experience, or a Bachelor’s/Master’s degree in life sciences with 6–10 years of medical or technical writing experience in the biopharmaceutical industry.
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Demonstrated excellence in scientific writing, with the ability to distill complex data into clear, accurate, and impactful content.
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Proven experience collaborating with cross-functional teams, including biostatistics, clinical, regulatory, manufacturing, and quality functions.
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Strong understanding of scientific principles, research methodologies, and global regulatory requirements.
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Experience with biologics and/or gene therapy products is preferred. Knowledge of ophthalmology or neuroscience fields is a plus.
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In-depth knowledge of the drug development lifecycle, regulatory submission processes and BLA submissions.
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Proficiency in Microsoft Office (Word, PowerPoint) and collaborative authoring platforms (e.g., SharePoint, structured templates).
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Familiarity with illustration or visualization tools in addition to using AI tools/platforms is a plus.
Working Conditions
This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
