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Supply Chain Study Manager Job

Eingestellt von Yoh

Gesuchte Skills: Design, Support

Projektbeschreibung

SUPPLY CHAIN STUDY MANAGER needed for a long term CONTRACT opportunity with Yoh's client located in GAITHERSBURG, MD.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Degree in supply chain related or drug development discipline or equivalent qualification or experience.
- Extensive experience (5+ years) working in supply chains
- Significant experience managing and influencing customer demands
- Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products In depth knowledge of R&D supply chain and drug development process
- In depth knowledge of Clinical Development processes relevant to the supply of clinical materials
- Experience of project management

WHAT YOU'LL BE DOING:

- Leads and provides direction to Study Drug Delivery Teams (SDDTs) comprising members of R&D SC, Clinical Development and external partners.
- Ensures SDDTs operate within boundaries set by Supply Chain Teams. Represents the Study Drug Delivery Team activities for all studies within a programme on the Supply Chain project team.
- Ensures expert input and support from cross functional groups.
- Escalate significant issues to SCT as appropriate
- Author the drug supply section of Clinical Study Protocol and lead development of master label text.
- Using this information, develop options for how the supply requirements of individual/groups of clinical studies can be delivered and propose to the Supply Chain Team. This will include sourcing (in or out) and alignment of sourcing activities with customers, detailed plans including timing of investments/cost expenditure (eg purchase of comparator product, phased spend at CROs), identification and management of risks.
- Define IVRS user requirements, set up IVRS tool and ensure timely go-live for individual studies. Use IVRS to track recruitment and adjust IVRS parameters to accommodate any changes in study scope and design.
- Collaborate with CRO partners in development of pack design and review the technical part of the outsourcing contract. Review changes to the contract with CRO partners and Sourcing Managers as necessary.
- Establish the supply chain for individual/groups of studies and ensure delivery of the end to end supply of materials to meet study needs.
- Monitor the budget for individual study supply activities and materials for the project. Flag deviations to SC Programme Manager.
- Maintain appropriate information for study supply activities to support updates in Portfolio Management System (Planisware).

WHAT YOU NEED TO BRING TO THE TABLE:

- Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
- Demonstrated technical skills and mindset in supply chain management including demand management, supply chain design/optimisation and delivery.
- Track record of good project management
- Risk identification and management
- Excellent written and verbal communication skills.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Experience in fluorescent focus forming assay and plaque assay would be highly desirable

WHAT'S IN IT FOR YOU?

Work for a multinational pharmaceutical and biologics company having a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Stephanie Tulloch

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAX TERM: CON_W2J2WNECLIN

Ref: AZNJP

SFSF: LS

Projektdetails

  • Einsatzort:

    Gaithersburg, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh