Publishing Coordinator

Région
Wavre
Publication
jeudi 6 avril 2017
Date limite
samedi 6 mai 2017
Réf
6A8DEXPE-BE
Contact
Andreea Ardelean
Fonction
Autre
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Publishing Coordinator Organisation description:

For one of its clients, XPE Pharma & Science is looking for a Publisher Coordinator profile. A good command of English is required for this mission. Knowledge of publishing tools (Liquent's Insight, CSC eCTDXPress, Publisher or similar) is a plus.

The responsible for this mission will produce, distribute and archive paper & electronic registration and post-registration submissions, meeting both internal quality standards and requirements of worldwide Regulatory Authorities, to ensure timely submissions.

Job description:

Accountability

 Manages and executes the timely publishing and distribution process for regulatory submissions (such as the initial submission file to obtain the Marketing Authorization Approval for Europe or international markets, dossiers for the WHO, complex variations, renewal files) to regulatory agencies.

 Maintains and continuously develops a high level of technical expertise of the submission tools and EU and international legislation in this context.

 Contributes to establish a performance dialog in terms of capacity management in capacity cross-business meeting for publishing activities.

 Develops and maintains Regulatory Affairs department operational databases to provide up-to-date reliable information systems within the department.

 Ensures archiving of regulatory dossiers (electronic and paper forms) for Regulatory Affairs Department.

 Flags operational issues and propose solution in a timely manners.

Complexity

 Ensures adherence to legal constraints, local and international standards, Regulatory requirements and all policies and procedures as applicable. The Publishing Coordinator is evolving in a complex and changing environment.

Profile:

Hard Skills

 Aptitude for working with electronic databases, publishing tools as well as the potential for managing complex information within regulated environments.

 Project management to compile and dispatch on time regulatory documentation.

 Experience in communicating to various stakeholders.

 Experience in highly regulated environment.

 Knowledge of the pharma industry and regulatory (operations) specifically is an advantage.

Soft Skills

 Good communication, presentation and influencing skills.

 Great motivation and team spirit.

 Structured and strong organizational skills.

 Rigor, quality minded and eye for detail.

 skills in information, document and database management.

 Good prioritization skills in function of business impact and critical.

 Skills in information, document and database management and publishing tools.

 Stress-resistant – Flexibility.

 Autonomous.

 Customer oriented.

Education, Methodology & Certification Requirements

 B.Sc. technical degree, or equivalent by expertise; Good standard of education level including English Language and basic IT tools

ICT Skills (software, operating systems, hardware, etc.)

 Documentum

 Publishing tools (Liquent's Insight, CSC eCTDXPress and Publisher or equivalent) is a plus

 MS Office

 Outlook

Language Proficiency Requirements

 English written and spoken

Offer:
  • Open end contract on XPE payroll;
  • Highly professional working environment.


Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713