Our Customer is a leading pharmaceutical Company
You will be responsible for coordinating the preparation of documents for regulatory submissions e.g. IBs, protocols, CSRs and writing strategic submission documents e.g. briefing books, clinical summaries. In addition you will act as primary contact for the Operations Team on medical writing deliverables/issues as well as providing project management expertise to manage process improvements, issue escalation and workload projection. Further tasks include reviewing and commenting on documents generated by vendors and manage deliverables and performing direct negotiations with CROs, e.g., timelines and further resources. You understand global regulatory requirements and ensure availability of submission-ready documents for assigned programs. Travelling up to 20% will be part of this role.
Minimum six years’ experience in Medical Writing
Demonstrated solid knowledge with writing briefing books, clinical summaries, responses to authorities, CSRs, IBs, CTPs etc.
Excellent time and priority management, work efficiently Strong organizational skills
Fluent in English (oral and written) – knowledge of an additional language may be beneficial
For more information please contact:
Kleen Linnebo und Partner Unternehmensberatung
Zum Bergwerk 1