Junior Regulatory Affairs Associate

Junior Regulatory Affairs Associate
Empresa:

(Confidencial)



Área:

Otros

Junior Regulatory Affairs Associate

Detalles de la oferta

Buenos Aires, Buenos Aires

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely,
combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

- Full Time
- Level: Mid
- Travel: Yes

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker

Rewards

- Global Impact

We are one truly global team working together to propel each client´s journey ahead faster.

- Balance

We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

- Collaboration

Work with industry leaders and subject matter experts.

- Freedom

The ability to innovate, ask “what if” and try new solutions without fear of failure.

- Variety

Opportunities to work on multiple accounts – never boring!

- Management

Strong management with depth of experience working for global health authorities.

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.

Do you have solid experience in document publishing and QC? Are you interested in working in a large global clinical research organization? We are looking for strong candidates who will have the ability to interact professionally within an international organization. In this role you will 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.

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.

Qualifications

- Solid experience with MS Office suite and Adobe Acrobat.
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline ie. Computer Translation
- Fluency in written and spoken English and Spanish
- Previous eCTD submission preparation experience is a plus as is QC experience using Insight Publisher


Fuente: Kitempleo


Área:

Requisitos


Conocimientos:

  • Access

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