job summary: Regulatory Publishing Specialist III Job Summary
The Regulatory Publishing Specialist III is responsible for the planning, publishing (paper, NeES, eCTD), review and delivery of regulatory submissions to global Health Authorities within required timeframes.
location: Cambridge, Massachusetts
job type: Contract
salary: $62.58 - 73.63 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- Primarily responsible for the planning and publishing of the lifecycle submissions portfolio, with accountability of monitoring the submission forecast and ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
- Liaise with GRA and R&D authoring groups to ensure paper and electronic submission requirements and timelines are mutually understood and in line with corporate standards. Manage deliverable and submission timelines to ensure on-time delivery to regional markets.
- Collaborate with GRO submission teams to ensure the submission portfolio is properly supported and work in a matrix environment to meet Shire's business needs.
- Publishing/Technical Responsibilities include timely preparation of submission ready components, assisting with publishing of global regulatory submissions and archiving of regulatory 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.
- 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 submissions.
- Maintain 100% compliance with company trainings and internal processes.
qualifications: Education & Qualifications
- BS or BA with submissions publishing experience and/or document management, or equivalent technical experience.
- Minimum of 3-5 years experience working within the pharmaceutical industry (Biotech, pharmaceutical or clinical research organization)
- 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.
- 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.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
skills: Regulatory Affairs Operations, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.