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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.What will you be doing?The Pharmacy Investigational (IP) Product Specialist (PIPS) will serve as a key contact point between the sponsor and the investigational site (both commercial and non-commercial) for Investigational Product Preparation Instructions (IPPI) training of studies with a complex IP preparation process. This role will focus on IPPI review and training/implementation of IP preparation steps for all compounds deemed requiring training plans. The Pharmacy Investigational Product Specialist will be the key internal and external interface to ensure overall IPPI adherence. He/she will contribute to continuous process improvement, training and mentoring for IPPI.The Pharmacy Investigational Product Specialist may perform Site Manager (SM) and/or Trial Manager (TM) tasks as described in GCO procedural documents for ED&CP studies (up to 40%).Required Experience:
BS degree in Pharmacy, Pharmaceutical Sciences or a related field
2-3 years of experience OR a MS, Pharm. D. or other advanced degree in Pharmacy, Pharmaceutical Sciences or a related field with at least 1-2 years of experience.
Preferred Experience:
Pharmacist License preferred
A minimum of 2-3 years of clinical trial research experience is required.
Experience in monitoring Early Development and Clinical Pharmacology studies preferred.
Experience in Oncology and Immunology Therapeutic Areas strongly preferred.
Experience with biologics preferred.
Experience with IV infusions and SC or IM injections required.
Experience in clinical practice within hospitals/academic centers strongly preferred.
Strong knowledge of the drug development process, including International Council on Harmonization (ICH)/Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), local regulatory requirements, assigned protocols and associated protocol specific procedures, including monitoring guidelines, required.
Experience working with computer software applications required.
Experience with clinical systems preferred.
Must have strong leadership, process initiative, influencing and mentoring skills.
Must have creative and flexible mindset with strong attention for details.
Must have good written and oral communication skills.
Must be proficient in speaking and writing the country language and English. Speaking an extra language (French, Spanish, German and/or Dutch) is an asset.
The ability to work at a fast pace within small exploratory study teams with accelerated cycle times is required.
The ability to work on multiple trials in parallel in different disease areas is required.
The ability to collaborate with all levels of management across a matrix organization is required.
Willingness to travel 50% (on a local and/or international level), approximately 2-3 days each week, with overnight stays, is required.
A valid Driver's License.
Why 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.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.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, colour, 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.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
