Clinical Compliance Specialist

3 settimane fa

Parma, Italia Chiesi Farmaceutici A tempo pieno

**Date**: 30-Mar-2023

**Department**: Global Clinical Development

**Team**: R&D, Pharmacovigilance & Regulatory Affairs

**Job Type**: Direct Employee

**Contract Type**: Temporary

**Location**:
Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).

Who we are looking for

Purpose

To contribute to the implementation of new and existing regulatory requirements about Clinical Trials in the Quality management system. To support the training activities on the SOPs and to raise awareness on best practices in Clinical trials.

Main Responsibilities
Assists manager in providing the Monitoring of Regulatory Requirements in relation to clinical trials.
Collaborates on development of standard operating procedures, trainings, and documentation. Delivers SOPs trainings.
Support process improvement efforts, assessment and alignment to the international standards, regulations and guidelines, and review of procedural updates as needed.
Participate in departmental initiatives across Clinical Dev. Dept sought at improving process and efficiency, in particular for the improvement of compliance processes.
Support audit-related activities and respond to internal audits including CAPA plans, training, procedure modification and implementation.
Experience Required

At least 3 year in clinical research regulatory and/or compliance

Education

Scientific degree (i.e. Chemistry, biology)

Languages

English fluent

Technical Skills
Good knowledge of ICH GCP, international (EU, US) regulatory requirements and company SOPs about Clinical Trial.
Good understanding of regulatory requirements about Clinical Trials and Clinical Trial Transparency.
Soft Skills
Analytical skills
Proactiveness
Attention to details

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

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