Job Title: Regulatory Publishing Specialist III
Duration: 06 months+
Location: Cambridge, MA
No Remote work possible
1. Global Publishing-US/Canada/Europe/Switzerland and possibly Australia
2. Able to hit the ground running with minimal training.
3. Solid experience with publishing tools (Liquent, Exted, eCDT Express) & Document Management.
The Regulatory Operations Specialist is responsible for the timely preparation of submission ready components, assisting with publishing of global regulatory submissions and archiving of regulatory correspondence/submissions. They will produce submission-ready documents, with emphasis on meeting company and health authority standards. They will also provide publishing support for electronic and paper regulatory submissions in accordance with global health authority standards. The Regulatory Publishing Specialist must demonstrate the ability to work independently and manage multiple priorities.
Summary of Key Responsibilities:
� 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.
Training & Education Preferred:
� BS or BA with submissions publishing experience and/or document management, or equivalent technical experience.
� Minimum of 1-3 years’ experience working within the pharmaceutical industry (Biotech, pharmaceutical or clinical research organization)
Prior Experience Preferred:
� Knowledge of the Drug Development Process.
� 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.
Desired Skills and Abilities:
� 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.