vor 2 Tagen

Senior Writing Manager

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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 Writing Manager

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:

 

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 documents owned by regulatory in collaboration with other functions (e.g. the IMPDs, INDs, Briefing Books, ODDs, PIPs or similar for the US, FTDs, BTDs and IND annual reports).
  • Proof read and provide editorial support on documents/responses produced by other functions, if requested.
  • Compile documentation to support high quality regulatory submissions and responses to questions from regulatory authorities.
  • Collaborate with the project lead responsible for regulatory affairs to establish timelines regarding regulatory document writing and submissions.
  • Contribute to reviewing/editing documents owned by other functions (e.g. clinical protocols, IBs, DSURs, CSRs…) if needed.
  • Bachelor’s degree in a scientific discipline; post-graduate scientific degree is preferred.
  • At least 5 years medical writing experience combined with the knowledge of drug development and regulatory requirements, plus extensive knowledge of medical writing processes.
  • Proven experience in writing regulatory documents such as briefing books, IMPDs, INDs.
  • Solid writing/editorial skills in English (English Native speaker is a plus).
  • Strong ability to prioritize and manage multiple demands and projects with respect to deadlines.
  • Ability to communicate scientific or medical information in a clear and concise manner.
  • Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously in cross-functional teams.
  • Must be able to work autonomously and attention to details.

Profile required

  • Bachelor’s degree in a scientific discipline; post-graduate scientific degree is preferred.
  • At least 5 years medical writing experience combined with the knowledge of drug development and regulatory requirements, plus extensive knowledge of medical writing processes.
  • Proven experience in writing regulatory documents such as briefing books, IMPDs, INDs.
  • Solid writing/editorial skills in English (English Native speaker is a plus).
  • Strong ability to prioritize and manage multiple demands and projects with respect to deadlines.
  • Ability to communicate scientific or medical information in a clear and concise manner.
  • Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously in cross-functional teams.
  • Must be able to work autonomously and attention to detail.

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.

CP 5911 /Chemin Messidor 5-7 1002 Lausanne