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Manager/ Sr. Manager Medical and Scientific Writer

Employer
Ocugen
Location
Malvern, Pennsylvania
Salary
Salary Range $165,000-175,000. Target Bonus and Equity
Closing date
Jun 15, 2024

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Discipline
Life Sciences, Biotechnology
Position Type
Full Time
Job Type
Manager
Organization Type
All Industry, Biotech

Job Details

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.

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.

Create 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).  

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