Associate Clinical Supplies Project Manager to Galderma Uppsala
Q-Med AB / Kemiingenjörsjobb / Uppsala
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hela Sverige Do you have experience of clinical supplies management? Are you interested in a role where you will interact with many different internal and external stakeholders globally and at Galderma to support clinical trials? Then you should keep reading! We are now looking for an Associate Clinical Supplies Project Manager for our Clinical Supplies Unit at Galderma in Uppsala.
In this role you will be part of a global team reporting to the Head of Clinical Supplies Management. The team is responsible for ensuring the availability of clinical trial supplies for assigned clinical studies on time, at the right quality and quantity, and in full compliance with applicable regulations.
Responsibilities
As Associate Clinical Supplies Project Manager you will serve as the primary link between clinical operations and the clinical supplies organization. You will contribute to the development of clinical protocols, providing input into the clinical trial supplies content thereby also supporting the supply chain planning process. Work tasks include:
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Defining forecast and demand of clinical supplies for all assigned studies, as well as monitoring the supply inventories.
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Optimizing the clinical supply chain through an efficient kit/label design and pragmatic use of depots
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Leading the development of study-specific label text in compliance with Galderma SOPs and applicable regulations. Project managing the approval flow of all text and proofs with required stakeholders as well as acting as the primary operational contact for packaging, labelling, logistics and depot vendors
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Collaborating with Procurement, Quality, Finance and CMC to set up Requests for Information, proposals to run bidding processes, and implementing relevant contractual documents
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Proactively interacting with Quality functions to provide documents and information as required for product release, and ensuring that complaints, deviations, CAPAs and change controls are managed in a timely and compliant fashion
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Ensuring that all study related GMP/GDP/GCP documents are accurate and filed timely as per Good Manufacturing Practices, Good Distribution Practice and Good Clinical Practices guidelines
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Set-up the packaging, labelling, storage and management of IMP with the internal and external stakeholders including setup and User acceptance testing of Randomisation and Trial Supplies Management (RTSM) vendors.
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Coordinate the Sponsor and Qualified Person/Quality Unit release of IMP in collaboration with both Quality Management as well as Regulatory Affairs, and any external partner.
Requirements
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Bachelor's degree in Science, Supply Chain, Drug Development or related field
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At least three years of solid experience in Clinical Trial Supplies management supporting international clinical studies.
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Excellent verbal and written communication skills in English and Swedish is a necessity, as is the ability to work in an international team environment with cross-functional interactions.
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You have a strong understanding of Clinical Operation processes in relation to pharmaceuticals and medical devices, as well as an understanding of regulatory affairs, GMP/GDP, and Good Clinical Practices requirements.
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You understand the needs of supply chain organization, including transportation studies, importation process and customs clearance.
To thrive in this role, you enjoy having a multifaceted role with much responsibility and have a passion for coordinating activities, as well as an ability to quickly switch from one activity to another.
Contact and Application
In Uppsala, Galderma is located by the river Fyrisån, a 10-minute bike ride from the central station. We work hard to offer personal and professional development, and work together to drive innovation within dermatology.
Have we sparked your interest? Please apply to the role via the button "Apply now", no later than Dec 12th. If you have questions, please contact the Head of Clinical Supplies Management at .
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2021-11-22ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2021-12-20
Klicka på denna länk för att göra din ansökanFöretagQ-Med AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "JR000157".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Q-Med AB (org.nr 556258-6882)
Arbetsplats Galderma
Jobbnummer 6121101
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