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Global Regulatory Submission Publisher
Ver: 163
Dia de atualização: 20-03-2024
Localização: Basel Basel-Stadt BS
Categoria: Marketing / PR Impressão / Publicação
Indústria: Research Services
Posição: Mid-Senior level
Tipo de empregos: Contract
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Conteúdo do emprego
This is an exciting contract opportunity in Basel for a top 10 Pharmaceutical company who seek a Global Regulatory Submission Publisher.This role can offer some remote working.The Role- Responsible for electronically preparing, publishing, quality reviews, and validation activities related to regulatory submissions
- Produce high quality, HA compliant submission
- Partners with Operations Submission Managers and a publishing team
- Comply with and actively apply internal work practices and guidelines.
- Support implementation of new technologies, tools and processes.
- Identify process or technical issues and propose solutions
- 5-8 years submission publishing experience in Pharma or related industry
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
- Effective interpersonal skills, strong written and oral communication and presentation skills.
- Project management and time management skills to manage multiple ongoing projects simultaneously.
- Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
- Working knowledge of regulatory affairs
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Data limite: 04-05-2024
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