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Senior Medical Writer - biotech pharma

We are looking for experienced pharmaceutical Sr. Medical Writer.
As a Senior Medical Writer you will be supporting a Top-tier pharma company. You have the chance to help our customer to deliver regulatory and submission documents. While being stably employed with us, you will be fully embedded with our client.

Main responsabilities:

* Independently produces clinical and regulatory documents in collaboration with Principal Medical Writers . These documents may include clinical study level documents such as clinical summary documents, protocols, CSRs, IBs, briefing books and response documents, PIPs .This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas.

* Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies.

* Acts as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents.

* Facilitates the review of the documents and ensures that documents are submission-ready and finally approved. When preparing documents you will be directly in contact with QC personnel and publishing specialists who support you in document preparation.

Requirements:

* Minimum requirement of a bachelor’s degree; Master's degree preferred

* 3-5 years Medical Writing experience in relevant pharmaceutical companies combined with scientific and regulatory knowledge (a must).

* Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured messages.

* Proficient in independently writing several types of clinical/regulatory documents (protocols, CSRs, etc.) including leading creation, coordination of the authoring functions, facilitation of the review of the documents and ensuring that documents are submission-ready and finally approved.

Please note that prior experience as regulatory writer (min 3 years) in a pharmaceutical setting is mandatory and only profiles who match the criteria will to considered for the next steps