Labeling TA Director and Group Manager
AstraZeneca Mölndal / Undersköterskejobb / Mölndal
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Successful candidates will be AstraZeneca Employees and will be located at one of th folliwing: AstraZeneca's MedImmune strategic science center in Gaithersburg, Maryland; Macclesfield, UK; or Molndal, Sweden. MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.
The Global Labeling TA Director and Group Manager (GLD) provide global labeling expertise, guidance, and support to GRAPSQA and cross functional teams within a TA to drive the development and maintenance of global labeling for all AZ products. Each GLD will be responsible for maintaining labeling expertise regarding a specific region (EU, US, RoW) or with respect to a key AZ function (e.g. Patient Safety, Operations) and serve as a point of contact for related issues. The GLD will serve as line manager for supporting Global Labeling Staff members and in conjunction with the Labeling Global Head will be responsible for hiring, training, coaching, and career development of supporting staff.
Typical Accountabilities:
Allocate GLG resources against product portfolio, aligning personnel with business priorities and individual development goals.
Ensure adherence to labeling development and maintenance processes that are consistently applied and followed across the TAs and which meets business needs and corporate standards.
Ensure labeling activities within assigned TA align with the TA's strategy. Together with the other GLDs ensure labeling activities are strategically aligned across the TAs and across the business.
Serve as a single point of contact for TA VPs for labeling related questions and issues.
Provide labeling expertise to GRAPSQA and other functions as needed during the development and maintenance of product labeling.
Responsible for the coordination of all related global and cross-functional activities related to the labeling process to meet established timelines.
Drive or lead the development of target labeling documents while working closely with the GRL and maintaining strategic alignment with the relevant TPP, TPC, and CDP.
Drive or lead preparation and maintenance of core labeling documents including the Core Data Sheet, Core PIL, and Core Packaging Text.
Drive or lead cross functional teams in the preparation and maintenance of EU SmPC and US PI and related texts while ensuring consistency with applicable core labeling documents and internal standards and SOPs.
Drive or lead development of labeling negotiation strategies, anticipating HA perspectives.
Ensure corporate review and approval of CDSs, USPIs, EU SmPCs and other regional prescribing information via product labeling teams and labeling governance.
Advise and support the creation and maintenance of other regional texts on an ad hoc basis (e.g. Japan, Canada, South Africa, New Zealand, Australia).
Ensure that .......
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www.astrazeneca.seVaraktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2015-10-05ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2015-11-23
Ange följande referens när du ansöker: MOL000001WI
FöretagAstraZeneca Mölndal
AdressAstraZeneca Mölndal
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
MÖLNDAL
Övriga kontaktuppgifterTelefonnummer: 031-7761000
Jobbnummer 2463533
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