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Job Details

Submission Specialist

Company: inVentiv Health Clinical
Location: Braine L'Alleud
Reference: IH/6102
Closing Date: 07 Dec 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

For our client, a global pharmaceutical organization we are currently looking for a Submission Specialist for the duration of 6 months. In this role you will be working from the Client's office in Braine L'Alleud.

Requirements:

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.



For our client, a global pharmaceutical organization we are currently looking for a Submission Specialist for the duration of 6 months. In this role you will be working from the Client’s office in Braine L’Alleud.



The responsibilities will be as follows:

* Planning, coordination, preparation and tracking of the documents needed for initial submission Start-up) and Substantial amendments (ongoing) of Clinical Study package for all countries (except US) in compliance with the Country Regulatory Requirements, EU clinical Trial directive, related Guidance, and BMS processes.
* Creation and collection of the submission documentation and compilation of the core dossier for an application to Competent Authorities (CAs) and/or Ethics Committees (ECs) to start, conduct and close a BMS sponsored Interventional Phase I – Phase IV clinical study in any of the countries BMS or collaborative partners targets to conduct the study in, except the US.



Main tasks:

* Determine the appropriate submission strategy and consistency of the Clinical Trial Application (CTAp) across projects, studies and countries.
* Effectively Lead Clinical Trial Application Tracking Meetings for the preparation of the CTAp dossier during start-up with cross-functional team and assure timelines and dossier quality are managed according to expectations.
* Liaise with local and central teams and CRO, as required, to ensure that study start-up activities are in compliance with study timelines and local regulations.
* Optimally compile and distribute the final Clinical Trial Application dossier (CTAp) and subsequent Substantial amendments to country applicants for submission to Ethics Committees and Competent Authorities.
* Communicate information and escalates issues, liaise with country offices and CSO, Operation Leads, Protocol Managers, Medical Monitor, QP and CROs (for outsourced studies) to ensure that study start up activities are in compliance with study timelines, BMS SOPs, local regulatory guidelines and regulations.
* Comply with the use and maintenance of the available planning & tracking tools (e.g. IRIS - HA submission and approval Tracking system) to generate reports and track the CTAp content and associated dates.
* Ensure Compliance with any revised Guidance & Regulations at EU and Country levels.



How to apply?

Are you ready to work alongside the brightest minds at INC Research/inVentiv Health? In this role you’ll be fully employed by INC Research/inVentiv Health and will enjoy our very competitive primary and secondary benefits. Please contact Eveline Wigtman or Irene Houtsma via

Apply for this job: Submission Specialist

Contact Information:

Address:  Main Office
Thames House, 17-19 Marlow Road Maidenhead, Berkshire
SL6 7AA, UK
England
Reasons to work for inVentiv Health Clinical
Tel:  +44 (0) 1628 408 408
Website:  Visit Our Web Site

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