Scientific Documentation Manager Lazio

Scientific Documentation Manager
Roma
Lazio, Lazio

Requisition ID: 6224- Location: Roma, IT- Company: ANGELINI PHARMA SPA- Professional area: Medical, R&D- Job Description:

**SCOPE AND RESPONSIBILITIES

1.

Build the Scientific Documentation Plan to guarantee the Business Continuity of the Company Products Portfolio, through the management of the related Product Dossiers.

2.

Set the planning of Scientific Documentation Projects, in collaboration with the Global Regulatory Affairs Dpt, through the appropriate management of the budget assigned.

3.

Manage the eCTD modules (Pre-clinical and Clinical) in line with the required standards and ensure timely the download in the relative company platforms as per Company Planning.

4.

Ensure continuous updating of the Product Dossier with reference to the current legislation.

5.

Identify External Partners for a timely and appropriate engagement to guarantee the correct planning and execution of the Projects.

6.

Create the Investigator's Brochure and Investigational Medicinal Product Dossier to meet the time to market of the Company Clinical Studies in cooperation with the other functions involved.

**SKILLS REQUIRED

Scientific Background

Role Experience: minimum 5 - 10 yrs

Portfolio Experience: Prescription Medicine, OTC, Medical Device

English Fluent