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Senior Regulatory Writer

Lausanne, Vaud, Switzerland · Regulatory Affairs & Market Intelligence

Description

Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of five companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investment management. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for worldwide marketing and sales.

For our Regulatory Affairs Department based in Lausanne, we are looking for a:

Senior Regulatory Writing

Reporting to the Global Head of Regulatory Affairs, you will be required to support the Global Regulatory Affairs Associate Directors in the preparation of regulatory documents.

Main responsibilities:

• Responsible for writing Regulatory Affairs led documents in collaboration with the regulatory core team member and other internal functions for example Investigational Medicinal Product Dossiers, Investigational New Drug Applications, Briefing Books, Orphan Drug Designation application, Fast Track and Breakthrough designation requests, Pediatric Investigational Plans (EU and US) etc.


• Collaborate with the Regulatory Affairs lead to establish a project plan for document writing, which will allow achieving submission target dates.


• When necessary, provide proof-reading and editorial support to regulatory relevant documents produced by other functions such as Protocols, Clinical Study Reports.

Requirements

Profile required

• Profile required :


• Bachelor’s degree in a health discipline; an advanced degree is preferred.


• At least 5 years medical writing experience within the pharmaceutical industry


• Proven experience in writing regulatory documents for FDA and EMA.


• Solid writing/editorial skills in English. English Native speaker is an asset.


• Ability to communicate scientific or medical information in a clear and concise manner.


• Excellent organizational, communication and time management skills needed to manage multiple simultaneously ongoing projects.


• Must be detail oriented and able to work independently.

Debiopharm International can offer you

• An international and highly dynamic environment.


• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.


• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

If you fit this profile please send your application.

For more information : www.debiopharm.com