Clinical Trial Regulatory Specialist
On behalf of our Client a global pharmaceutical company, IQVIA is looking for a Clinical Trial Regulatory Specialist who can join an exciting working environment in a dynamic atmosphere.
- Be R&D Project and Portfolio Management Department point of reference within the function regarding expenditures, workload and compliance topics.
- Ensure set up of necessary activities to upload and continuously update OPEX/CAPEX/workload data in relevant projects into the planning system
- Guarantee the consistency of these values with those present in SAP system
- Keep track and provide justifications regarding the deviations from planned spendings
- Plans in agreement with Project Manager and the authors/reviewers/approvers the Investigational Medicinal Product Dossier (IMPD) production/update needed by Global Clinical Development (GCD) Dept.
- Moreover, he/she is responsible for the revision of the structure of the documents and for finalisation process.
- Outlines, corrects, assembles, and edits the IMPD Coordinates the preparation of the sections of IMPD in EDMS (Electronic Documentation Management System).
- Prepares the IMPD documentation list and check with CPM the location of benefit/risk paragraph in protocol
- Releases the final version (e-signature)
- Informs Study Tea, Global PV and QP of the IMPD release indicating composition and location in EDMS
- Coordinate the redaction of the documents.
- Prepares and releases IMPD updates when it needs to be amended.
- Prepare/update and put in place/supervise the Investigator Brochure (IB) needed by GCD. Moreover, is responsible for the revision of the structure of the documents and for finalisation process. Prepares the action plan for the IB production in agreement with the PM.
- Prepares and coordinates the workflow in EDMS for IBs drafting, review, approval.
- Finalizes the IB and approves it. Coordinate the redaction of the IB.
- Releases confidential copies of IB for external distribution other than for clinical trials.
- Initiates the verification -at least annually- of the IB and triggers update, if necessary.
For Regulatory processes:
- Prepare/update and put in place/supervise compliance of clinical regulatory documents/processes for submissions/follow-up to Regulatory Authorities and Ethic Committees ensuring completeness of documentation submitted.
- To ensure communication between Depts to have aligned information on common regulatory documents to be provided for clinical trial submission/follow-up.
- Update the International regulatory environment database for each country participating in Companys R&D corporate clinical trials to contribute to the choice of CT submission strategies.
Requirements and skills:
- High level scientific degree (i.e. pharmacy, biology)
- 3-5 years of experience in Clinical Research and Regulatory Affairs Good communications skills
- Interpersonal skills
- Priorities setting
- Team working
- Time management
- Orientation to quality
- Ability to work in a matrix
- Orientation to details control
- Planning & organising
- Regulatory thinking
- English knowledge
Type of contract: Long Term contract Staff Leasing
20 settembre 2022