Clinical Study Supply Lead
Clinical Study Supply Lead - 12 Month Fixed Term Contract/ Secondment
Location: Macclesfield, Cheshire, UK
Competitive Salary & Benefits
Date Posted: 04.01.22
Make a positive impact, in a team where it means more
In Operations we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.
In Pharmaceutical Technology and Development (PT&D) we are the bridge which turns forward-thinking science into actual medicines that help millions of people around the world. We work across the entire value chain, crafting and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.
Would you like to utilise your supply chain knowledge and skill base to lead clinical supplies for your portfolio of global clinical studies? The Clinical Supply Study Lead (CSSL) is a key role within our Clinical Manufacturing and Supply teams. This role involves running a portfolio of studies across all phases of a drug development programme ensuring on time delivery to patients.
What you'll do
Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply, following defined business processes
Lead the Study Drug Working Group and contribute to the Supply Chain Team Meetings enabling continuous cross-functional dialogue with both internal and external partners on study design requirements and associated changes which may impact the supply chain elements of the study
Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls
Understand customer demand requirements and have the ability to translate this into a supply plan
Manage the Interactive Response Technology (IRT) system to execute demand and supply planning
Take ownership for Inventory management, utilising systems such as Smart Supplies, including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction
Ensure effective communication with project teams and key partners across a global network
Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies, ensuring consistent on time delivery of drug to patient
Monitor the budget for your individual study supply activities and materials for the project including packaging, labelling and distribution costs
Required Skills & Knowledge
Bachelors Degree in a scientific or business subject area – equivalent experience will be considered
Experience within a supply chain environment or pharmaceutical industry
Holistic knowledge of end to end supply chain activities
Experience and proven track record of successful demand and supply planning
Experience in running projects and inﬂuencing customer demands
Analytical aptitude, showing strong data analysis skillbase and ability to utilise dashboards
Strong inﬂuencing, negotiating and problem-solving skills, across geographical and cultural boundaries
Risk identification and management
Excellent written and verbal communication skills
Proficient IT skills with an ability to adapt and operate in bespoke multiple systems
Desirable Skills & Knowledge
Awareness of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practice)
Knowledge of clinical development processes relevant to the supply of clinical materials
Experienced in handling Quality Events (Deviations, Change Controls, Complaints)
Use of either SmartSupplies or SAP would be an advantage
Good working knowledge of planning applications
With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.
So what's next?
Please submit your application by the close date, 17th January 2022
Close Date: 17.01.22
Where can I find out more?
Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.