Ref #: 30173

Employment type: Permanent - Full-Time

Location: Italy

Posted: 23-Jun-2021

Description

The role:

• providing sustainable solutions to deliver medical affairs projects/activities.
• providing insights about risks (by navigating and complying within internal
processes, requirements and regional/local regulations).
• streamlining an efficient communications and co-creation of content shared across Global/Region/Country.
• monitoring and giving feedback to improve processes, systems and capabilities, with clear quality and performance metrics, a defined follow up and escalation process to accelerate country support and decision making.

To be successful in the role, you will have:

• Lead the End-to-End medical governance of local regulated activities (Interventional and Non Interventional Studies/Real World Evidence, Investigators Initiated Trials, Managed Access Programs, Research Collaborations), in alignment with Medical Affairs strategy and priorities
• Monitor adherence to internal processes, standards and Country regulations through the execution of periodic self-inspections with project owners, production of report and finalisation of potential corrective action plan
• Support data quality/integrity in Country Medical Dept.
• Provide governance support, advice, coaching and expert input to the Country Medical Dept activity owners and teams.
• Is the local expert on Med Affairs processes, standards and Country regulations.
• Ensure proper classification of the medical activities, in collaboration with Ethics Risk and Compliance (ERC) if needed.
• Proactively identify risk and support risk management and mitigation
• Maintain overview and monitor progress of R/C issues, ensure & track escalation and follow-up until resolution.


Education/Experience:

•Education Scientific Degree, PhD, PharmD or equivalent.
•Italian mother tongue
•English – fluent (oral & written)


What is Offered:

We offer a permanent contract, full time role based in Italy
We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.


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