Applied Genetic Technologies Corporation (AGTC) is a clinical stage biotechnology company dedicated to developing novel gene therapies with an initial focus on ophthalmology. AGTC is seeking a highly motivated individual to edit, authorize and manage regulatory and quality documentation that supports product development activities in compliance with cGXP requirements.
• The Documentation Specialist will report directly to the Senior Director, Regulatory Affairs and will have dotted line reporting to the Director, Quality Assurance.
Essential Duties and Responsibilities
• Assist in the preparation of regulatory documentation for submissions, including routine correspondence, INDs, BLAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, etc.
• Manage and control manufacturing and laboratory documentation, including SOPs, study protocols, study reports, batch production records and other controlled documents
• Edit and format documents for consistency and compliance with applicable department, company, and regulatory standards and circulate in accordance with established procedures
• Ensure the proper filing and organization of regulatory and quality documentation
• Coordinate the review and revision of regulatory and quality documentation
• Assign and monitor document numbers and review documents for accuracy and completeness
• BS degree (scientific discipline preferred) and 2 to 5 years’ experience working in a GLP/GMP environment, preferably in a biotechnology company
• Strong proficiency in Word, Excel and Adobe Acrobat
• Experience with the Common Technical Document (CTD) format
• Effective communication skills both verbally and written
AGTC offers a competitive compensation commensurate with education and experience, including salary, benefits, and company equity. AGTC is an EOE and maintains a drug free workplace.