Staffing and Recruiting

Vality One Recruitment GmbH

11-50

Germany

## Ihr Aufgabengebiet

* Writing clinical documents for submission to regulatory authorities
* Promote the document drafting process
* Receive and review primary statistical material, draft documents for review, and include/clarify comments with all reviewers
* Conduct literature searches to support writing activities
* Supporting project teams by providing scientific/medical advice
* Medical and editorial review of drafts and final documents prior to distribution
* Coordinate and work closely with Medical Experts within the organisation
* Oversee documents that have been outsourced to other medical writing CROs

## Ihr Hintergrund

* Completed scientific studies
* Solid experience in the field of medical writing (oncology indication would be a plus)
* Strong knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.)
* Solid experience with global marketing authorisation applications for medicinal products (MAA/NDA)
* Excellence written and spoken English skills

## Ihre Benefits

* Spannende Herausforderungen in einem zukunftsträchtigen und wachsenden Unternehmen
* Eine offene Arbeitsatmosphäre in einer offenen Unternehmenskultur mit kurzen Kommunikationswegen
* Ein attraktives Vergütungspaket sowie interessante Weiterentwicklungsmöglichkeiten

Gender-Hinweis

Aus Gründen der besseren Lesbarkeit
wird auf die gleichzeitige Verwendung
der Sprachformen männlich, weiblich
und divers (m/w/d) verzichtet.
Sämtliche Personenbezeichnungen
gelten gleichermaßen für alle
Geschlechter.

Employee

<h2 id="ihr-aufgabengebiet">Ihr Aufgabengebiet</h2>
<ul>
<li>Writing clinical documents for submission to regulatory authorities</li>
<li>Promote the document drafting process</li>
<li>Receive and review primary statistical material, draft documents for review, and include/clarify comments with all reviewers</li>
<li>Conduct literature searches to support writing activities</li>
<li>Supporting project teams by providing scientific/medical advice</li>
<li>Medical and editorial review of drafts and final documents prior to distribution</li>
<li>Coordinate and work closely with Medical Experts within the organisation</li>
<li>Oversee documents that have been outsourced to other medical writing CROs</li>
</ul>
<h2 id="ihr-hintergrund">Ihr Hintergrund</h2>
<ul>
<li>Completed scientific studies</li>
<li>Solid experience in the field of medical writing (oncology indication would be a plus)</li>
<li>Strong knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.)</li>
<li>Solid experience with global marketing authorisation applications for medicinal products (MAA/NDA)</li>
<li>Excellence written and spoken English skills</li>
</ul>
<h2 id="ihre-benefits">Ihre Benefits</h2>
<ul>
<li>Spannende Herausforderungen in einem zukunftsträchtigen und wachsenden Unternehmen</li>
<li>Eine offene Arbeitsatmosphäre in einer offenen Unternehmenskultur mit kurzen Kommunikationswegen</li>
<li>Ein attraktives Vergütungspaket sowie interessante Weiterentwicklungsmöglichkeiten</li>
</ul>
<p>Gender-Hinweis</p>
<p>Aus Gründen der besseren Lesbarkeit
wird auf die gleichzeitige Verwendung
der Sprachformen männlich, weiblich
und divers (m/w/d) verzichtet.
Sämtliche Personenbezeichnungen
gelten gleichermaßen für alle
Geschlechter.</p>


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Accountant & Key User Navision/Business Central (gn) (gn)

Area Sales Manager - Medizintechnik Bayern (gn) (gn)

Director Commercial Contracting (gn) (gn)

Director Computational Biology & Data Science (gn) (gn)

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