Student Internship in Medical Writing in Regulatory Affairs Documentation (6-12 months)

Job description

  Job facts

The Product Development Regulatory Documentation Group (PDRD) is responsible for preparing clinical and safety regulatory documents based on clinical trial data, to support drug development programs in accordance with Health Authority guidelines. We are a highly motivated global team of Regulatory Documentation Scientists (Medical Writers) located in Switzerland, UK, US and Canada. As an intern in our group, you will be offered an excellent opportunity to combine your scientific knowledge and writing skills to get hands-on work experience in clinical and safety regulatory documentation.

During the internship you will:

·  Support the planning and management of documents, e.g. Clinical Study Reports, Investigator Brochures.
·  Actively assist in the preparation of a wide variety of scientific clinical and safety documents for regulatory purposes under the mentorship of a member of our staff.
·  Interact with the global clinical and regulatory project teams to enable your work.
·  Participate in team meetings to learn about the scientific and regulatory project strategy.

You will learn during this internship:

·  About the steps involved in preparing a regulatory document and how the documents make up the Dossier that is submitted to the Health Authorities.
·  About the many aspects of clinical drug development such as clinical studies.
·  About the Regulatory processes that must be fulfilled to bring medicines to patients.
·  About Regulatory Health Authorities worldwide and how Roche interacts with them.
·  About the Roche culture and values.

·  Who we are

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more .

Roche is an equal opportunity employer.

Desired profile

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You are currently enrolled at an university in Life Sciences, Pharmaceutical Sciences or a related field.

Moreover you are/have:

·  Passion for data analysis and scientific writing.
·  Able to independently perform tasks assigned and research unfamiliar topics.
·  Excellent written and verbal communication skills.
·  Advanced proficiency in English (writing and speaking).
·  Experience in scientific writing/publication (a plus).
·  Minimum of a BSc in relevant science field, higher degree preferred.

Applications need to include a CV and a motivation letter. Please clearly mention your preferred start date and duration (6-12 months) and detail how your experience and personal attributes make you suitable for this role. Applications lacking a cover letter will not be considered.

Due to regulations, non-EU/EFTA citizens must provide a certificate from the university stating that an internship is mandatory as part of the application documents.

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