Regulatory Publishing Specialist
Where
- Lexington, MA
What you'll be doing
- Provide document formatting support to ensure consistency with company and health authority submission ready standards. Review documents for submission-readiness and conformity company and health authority guidelines. Support the publishing for both paper and electronic regulatory submissions: submission build activities, ensuring submissions are built with submission-ready documents, creating inter-document links, performing quality check and validating compiled submissions, and finalizing submission by required dispatch date. Support the archiving and logging of regulatory correspondence and submissions. Maintain 100% compliance with company trainings and internal processes.
What your background should be
- Minimum of 1-3 years experience working within the pharmaceutical industry Biotech, pharmaceutical or clinical research organization. Knowledge of the drug development process, global regulator, ISI Toolbox, Liquent, Extedo, eCTD. Knowledge of global regulatory requirements with a strong focus on US, EU, ICH requirements. Solid experience with document management and electronic publishing systems. Ability to manipulate large and complex documents required for submissions. Attention to detail with the ability to multi-task. High level of expertise in Microsoft Suite of products required, Adobe required and ISI Toolbox preferable. Solid experience with submission publishing tools e.g. Liquent, Extedo, eCTD Express and document management systems.
Required Schooling / Training
- BS or BA, or equivalent technical experience.
Who is the client company
- The company is a fast-growing premier global pharmaceutical company that provides end-to-end services in pharmaceutical industry round the globe.
- If you are interested in this position, send your resume to apply@kochdavis.com
