Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.
What we are looking for?
We are currently recruiting bi-lingual (English and Spanish) Junior Associates to join Parexel’s Regulatory Operations Team in our Buenos Aires office. Our Regulatory Operations Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks.
- Assist in the production of submissions and delivery of regulatory services in accordance with defined agency guidelines while balancing the quality and timeliness of customer deliverables.
- Under the general direction of a Project Lead, you will be responsible for ensuring that client work is performed, and delivered on time, meeting the quality expectations of Regulatory Outsourcing Services and the client.
- You must have experience in document publishing ideally using Adobe Acrobat bookmarks and hyperlinks as well as submission preparation and QC using Insight Publisher.
- Preference will be given to those with a related University degree, especially English Translators.
- Fluency in written and spoken English is required.
- Due to Parexel's global presence and global clients, our Regulatory Operations Team works shifts. We currently have an opening to work the afternoon shift from 2:00pm to 10:00pm Argentinian time.
- Solid experience with MS Office suite and Adobe Acrobat.
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline ie. Computer, Translation, Edition, etc.
- Fluency in written and spoken English and Spanish
- Previous eCTD submission preparation experience is a plus as is QC experience using Insight Publisher