Job Summary
A gene therapy company has an open position for a Remote Publishing Operations Associate Director.
Individual must be able to fulfill the following responsibilities:
- Applying in-depth knowledge of US, EU, and ROW submission requirements and standards
- Managing and leading publishing activities as well as publishing documents as an individual contributor
- Providing creative solutions and successfully spearheading new initiatives
Applicants must meet the following qualifications:
- Bachelor's degree in life-sciences, computer science or related field
- 7 years of experience in regulatory operations with a focus in dossier publishing
- 5 years in delivery of timely and compliant submissions including eCTD, marketing and clinical
- 5 years in serving as point person for publishing activities and sharing best practices within area of specialization
- 5 years in applying advanced knowledge in publishing activities
- 3 years in applying in-depth knowledge of US and EU submission requirements and standards
