Regulatory Submission Publisher

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
6 months
Von:
ITech Consult
Ort:
Basel-Stadt
Eingestellt:
23.10.2012
Land:
flag_no Schweiz
Projekt-ID:
437801

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Reference Nr.:
8861TG

Industry:
Pharmaceuticals

Place of work:
Basel

Start:
ASAP

Duration:
6 months

Introduction:
ITech Consult AG is a Swiss Recruitment Agency with profound experience in matching the needs of our clients with the perfectly suitable IT experts within various industries. Currently, we are looking for an experienced Regulatory Submission Publisher for one of our clients in the Pharmaceutical industry.

Role:
-Global Submission Publishing of all submissions from a Global perspective and dispatches to worldwide Health Authorities (FDA, EMA, LATAM, ROW). Accountable for all Publishing, verification, dispatch and management of submission dossiers for all (investigational, marketing authorization, life cycle management, post approval change management) drug dossiers (e-CTD, NEES, Paper).
-Liaises with a team of Publishers located in different countries. Works in a global capacity with colleagues across these regions. Support the rest of the global publishing team and other temporarily assigned staff in preparation, quality review, and timely dispatch of drug dossiers
-Works in close collaboration with the managers, assigned to respective franchise/activity with clear accountability for publishing process
-Provides strategic and operational expertise to teams for routine or maintenance submissions to ensure the timely, quality preparation and execution for electronic and paper submissions to Global Health Authorities (EMA, FDA, Swiss Medic, LATAM, ROW)
-Supports implementation of Technical Format requirements and collaborates with Submission Standards and Strategy team members to develop a company business guidance on publishing deliverables
-Responsible for managing all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned maintenance regulatory submissions for assigned franchise. Ensure adherence to internal standards and processes, as well as Health Authority's requirements.
-Partner with Clinical, Preclinical, Research and Technical Coordinators (or designee) to negotiate every submission component target date with the goal of achieving the target submission date for minor submissions.
-Reports and updates management on submission progress and provide monthly report to line management.
-Identify issues and solutions relating to timing, quality and resources.
-Continuously looks to improve the submission process (ie, updates existing business processes, authors new processes, etc.) and knowledge transfer.
-Represents department on cross-functional project teams (non-submission related activities).
-Participates in other department activities/initiatives as required.

Requirements:
-Knowledge of either Liquent InSight Publisher software or ISI eCTDXPress/Publisher in order to produce NeeS, eCTD and paper submissions
-BS or MS or with comparable relevant experience and demonstrated capability
-1-5 years of experience in the pharmaceutical industry, with relevant experience in electronic submission publishing, dossier management and dispatch of global drug dossiers
-Expert in HA submission publishing requirements globally
-Strong knowledge, of Regulatory Business processes and related tools (document management, publishing, etc)
-Excellent verbal and written communication skills
-Proven negotiation skills
-Team management experience with cross functional re-sponsibilities
-Demonstrated ability to be innovative and a creative thinker
-Demonstrated ability to manage and develop associates
-High level of organizational awareness

Language:
Fluency in English as a business language (oral and written)