Job Purpose

The Manager, Medical and Scientific Writer is responsible for authoring and subsequent maintenance of technical documentation related to the development of Ocugen’s product portfolio. This position reports director to the Associate Director, IP, Scientific Publications.

Duties and responsibilities

• Authoring, analyzing, and interpretation of CMC, non-clinical toxicology and pre-clinical efficacy related technical data (from development reports, SOPs, Batch Records, Reports, etc.) to author Pre-INDs, INDs, BLA and IMPD sections, briefing documents, and other documents needed to support regulatory interactions and filings.
• Authoring of Orphan Drug Designation (ODD) requests based on the pre-clinical efficacy data and disease prevalence and submitting to FDA for the ODD designation in collaboration with regulatory partners.
• Performs quality control (QC) and editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.
• Reviews and aids in responding to requests for information from regulatory agencies, as required.
• Manages the review and approval of documents needed for regulatory filings.
• Assist in drafting presentations, papers, and publications related to discovery and preclinical studies.
• Performs literature search on new discovery programs and authors new project proposals in collaboration with Discovery Scientists.
• Manages and communicates document-specific timelines to team members to ensure on-time deliverables are completed.

Qualifications

• A minimum of 6-10 years of technical writing experience in the biopharmaceutical industry plus BS or MS in a life-science- related discipline, health-related field, or PhD with a minimum of 3 years of experience.
• Excellent scientific writing skills with ability to edit complex material to ensure accuracy, clarity, and effectiveness.
• Demonstrated experience working with document contributors, including analytical experts, biostatistics, manufacturing operations, quality assurance and regulatory affairs to ensure appropriate collaboration and input into document development.
• Previous experience with and expert knowledge of cGMP guidelines is a plus.
• Should have experience working with biologicals and/or gene therapy-based products.
• A solid understanding of the drug development process, including documents that are required at each stage of the regulatory submissions. Project management experience is a plus.
• Strong proficiency in standard Microsoft Office applications g. MS Word and MS PowerPoint. Working knowledge of EndPoint, Starting Point, Share Point and other referencing and collaborative authoring tools.
• Skill with illustration software like Biorender or Photoshop is a plus.

Working Conditions

This job requires a person to work full time in the office space. This person may have to travel occasionally for business purpose.

Physical Requirements

There is no special physical requirement for this job.

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.