Senior Manager, Medical And Scientific Writer Clinical

Job Details

Job Location: Main Corporate Office - Malvern, PA

Salary Range: Undisclosed

Description

Job Purpose

Scientific Writer for Clinical Operations at Ocugen, Inc. plays a pivotal role in ensuring the clarity, accuracy, and effectiveness of technical documentation related to our clinical operations. This role develops protocols for cross-project consistency and identifying standard case report form modules to meet objectives, as well as communicating key scientific findings to various stakeholders.

Duties and Responsibilities

• Author and analyze technical data pertinent to clinical operations, including CMC, non-clinical toxicology, and pre-clinical efficacy data, to support the development of regulatory documents such as Pre-INDs, INDs, BLAs, and IMPDs.

• Collaborate with regulatory partners to prepare Orphan Drug Designation (ODD) requests based on pre-clinical efficacy data and disease prevalence, submitting them to FDA.

• Conduct quality control and editorial review of documents prepared by team members to ensure completeness, accuracy, consistency, structure, and grammar.

• Assist in responding to requests for information from regulatory agencies.

• Manage the review and approval of documents required for regulatory filings.

• Support the drafting of presentations, papers, and publications related to clinical studies.

• Creation of detailed documents outlining the procedures and guidelines for conducting various scientific experiments, clinical trials, or research studies.

• Conduct literature searches on new discovery programs and contribute to the development of project proposals.

• Communicate document-specific timelines to team members to ensure timely completion of deliverables.

• Synthesizing complex scientific information into clear, concise, and well-structured documents that can be easily understood and followed by researchers, clinicians, and other stakeholders involved in the studies.

Qualifications

• MD or PhD degree in a life science-related discipline, health-related field.

• 6-10 years of technical writing experience in the biopharmaceutical industry.

• Excellent scientific writing skills with the ability to edit complex material for accuracy, clarity, and effectiveness.

• Experience collaborating with cross-functional teams, including analytical experts, biostatistics, manufacturing operations, quality assurance, and regulatory affairs.

• Deep understanding of scientific concepts, research methodologies, regulatory requirements.

• Previous experience working with biologicals and/or gene therapy-based products is preferred.

• Strong understanding of the drug development process and regulatory submissions.

• Proficiency in Microsoft Office applications (Word, PowerPoint) and collaborative authoring tools (Endpoint, Starting Point, SharePoint).

• Skills with illustration software a plus.

Working conditions

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

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.