Do you have experience in publishing key regulatory submissions and want to extend your experience in one of the biggest Pharma companies? Don't hesitate and apply today !
Job Description
As an Expert Regional Dossier Publisher, you will work with the Global Regulatory Affairs and Clinical Safety organization, in the EMEA Regulatory Operations but will provide support to the RRO organization globally.
You are responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by the regional publishing team who are working on dossiers for the region. You will have a good knowledge of the regulatory procedures and dossier requirements in the region and will be able to apply this to the publishing processes and tools to ensure that the submissions delivered to the Country RA groups meet their specific needs.
You will also be involved with supporting Country RA teams with their local publishing and submission transmission needs and ensure they can meet their submission deadlines. The role will assist HQ Colleagues within RPP in the development of the tools and procedures that support our submission publishing procedures
Responsibilities
- You will be the regional expert for regulatory submission capabilities, including dossier structures and file formats, electronic submissions, and transmission (e.g., agency gateways), dossier repositories and databases.
- You will be responsible for identifying and maintaining dossier format requirements supporting regulatory dossier assembly (aka publishing) and delivery to regulatory health authorities or to the country organization in the region.
- You will support the maintenance of related processes in accordance with regional/country requirements and will support the central publishing team responsible for the execution of the assembly processes.
- You will play an advocating role for standardization across the supported countries within the region.
- You will lead technical impact assessments of regional/country requirements for regulatory submissions and serve as the technical expert for local Country RA teams. You will provide training to the Country RA teams on the publishing processes.
- You will serve as the technical expert and point of contact for health/regulatory authorities in the region.
- You will support the maintenance of processes and systems related to the assembly and delivery of regulatory submissions.
- You will also perform publishing in executing the assembly and delivery processes to meet critical submission targets.
- As submission publisher, you will participate to "Improvement process and tools project" by taking part of system testing, performance measures and other efforts necessary for readiness.
- As submission publisher, you will support the technical validation process.
- You will play a role as Mentor/Coach/Manage external sources publishers.
Requirements
- Minimum 4 years publishing experience with Liquent Insight Publisher, knowledge of other publishing tools will be considered as a plus.
- Strong analytical and customer service skills with the ability to work with varying grade levels, educational background, and departments.
- Demonstrated ability to work under tight deadlines.
- Proven attention to detail and ability to work with a variety of technical applications.
- Working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project, Documentum).
- Knowledge of publishing requirements in the EU, EEMEA, APAC and LATAM regions.
- Knowledge of the regulatory registration procedures in the EU, EEMEA, APAC and LATAM regions will be considered as a plus.
- Excellent English skills are mandatory.
Benefits
- Permanent contract with Oxford Global Resources.
- Can be done fully remotely.
- Full-time.
