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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Role:
What will you be doing as Senior Quality Process Specialist:
Perform tasks relevant to the assigned Quality & Compliance function including but not limited to two main activities:
Conducting Snapshots - Internal Quality Assessments
Fulfilling role of Q&C Business Partner during the SOP Harmonization
What is means:
Provide support to all roles for EDMS activities, Documentation guidance, Training identification and Cross SOP Harmonization workstream communications
Perform review of relevant study data as Trial Master File and other relevant data source
Have a thorough knowledge of all relevant SOPs, and appropriate regulations and guidelines. Understand key business drivers; uses this understanding to accomplish own work.
Build knowledge of the company, processes and customers.
Conduct departmental and ICON staff training regarding ICON's quality system, Q&C tasks & processes, applicable standards, regulations; mentor new or developing Q&C staff as assigned, including providing constructive and effective feedback to trainees regarding skill capabilities during training.
Assume additional responsibilities, which are directed by the Q&C Manager or higher.
Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
To be successful in the role, you will ideally have:
Background in medicine, science and/or other relevant discipline and appropriate experience.
Experience within Clinical Research Environment (e.g. CRA, Data Management) an advantage.
Ability to review and evaluate clinical data / records.
Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
Detailed understanding of drug development and clinical trial process.
Good problem resolution skills.
Good planning and organizational skills with the ability to multi-task.
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 through the form below.