Clinical Supply Study Lead

Can you envision using your supply chain knowledge to lead clinical supplies for global clinical studies? Would you like to apply your expertise to impact the development of medicines to patients? Then AstraZeneca is the place for you!

We have exciting opportunities for two hardworking Clinical Supply Study Leads (CSSL) to join our team in Gothenburg, Sweden. This is a key role within our Clinical Manufacturing and Supply teams and involves running a portfolio of studies across all phases of a drug development programme ensuring on time delivery to patients. 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.


WHAT YOU'LL DO
AS A CLINICAL SUPPLY STUDY LEAD, YOU WILL PROJECT MANAGE THE DELIVERY OF CLINICAL SUPPLIES EFFECTIVELY AND CONSISTENTLY, AND INPUT TO THE BALANCE OF COSTS AND ANY RISKS TO SUPPLY. YOU WILL ALSO 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.

WE WILL RELY ON YOU TO:
• MONITOR THE BUDGET FOR YOUR INDIVIDUAL STUDY SUPPLY ACTIVITIES AND MATERIALS FOR THE PROJECT, INCLUDING PACKAGING, LABELLING AND DISTRIBUTION COSTS
• WORK WITHIN GMP QUALITY MANAGEMENT SYSTEMS, ENSURING THAT YOU ACTIVELY HANDLE ANY DEVIATIONS, COMPLAINTS AND CHANGE CONTROLS
• MANAGE THE INTERACTIVE RESPONSE TECHNOLOGY (IRT) SYSTEM, TO EXECUTE DEMAND AND SUPPLY PLANNING
• TAKE OWNERSHIP FOR INVENTORY MANAGEMENT, 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

ESSENTIAL FOR THE ROLE
WE BELIEVE THAT YOU HAVE A BACHELOR’S DEGREE IN A SCIENTIFIC OR BUSINESS SUBJECT AREA, ALTERNATIVELY EQUIVALENT EXPERIENCE. THIS IS COMPLEMENTED BY EXPERIENCE FROM A SUPPLY CHAIN ENVIRONMENT OR PHARMACEUTICAL INDUSTRY.
COLLABORATION IS KEY IN THIS ROLE, AND YOU HAVE GREAT INTERPERSONAL SKILLS. YOU HAVE A TRACK RECORD OF DRIVING SUCCESSFUL COLLABORATIONS ACROSS LOCATIONS AND SPECIALIST FIELDS.

YOU ALSO POSSESS:
• A HOLISTIC KNOWLEDGE OF END TO END SUPPLY CHAIN ACTIVITIES
• PROVEN EXPERIENCE OF DEMAND PLANNING AND FORECASTING
• SOLID EXPERIENCE IN RUNNING PROJECTS AND INFLUENCING CUSTOMER DEMANDS
• TRACK RECORD OF PREVIOUS RISK IDENTIFICATION AND MANAGEMENT
• PROFICIENT IT SKILLS WITH AN ABILITY TO ADAPT AND OPERATE IN BESPOKE MULTIPLE SYSTEMS

WE TRULY BELIEVE THAT EVERYONE CONTRIBUTES WITH A UNIQUE SET OF COMPETENCE. YOUR CURIOSITY AND PASSION FOR PERSONAL DEVELOPMENT COMBINED WITH SUPPORT FROM COLLEAGUES, MENTORS AND LEADERS, WILL ENSURE YOU MAXIMISE YOUR SKILLS, ABILITIES AND CONTRIBUTION.

DESIRABLE FOR THE ROLE
• Awareness of GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice)
• Knowledge of clinical development processes relevant to the supply of clinical materials
• Knowledge and understanding of Lean
• Experienced in handling Quality Events (Deviations, Change Controls, Complaints)

 

ABOUT ALTEN
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams! As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.

 

We believe in growing together!