Medical Scientist, Early Clinical Development
AstraZeneca Mölndal / Biomedicinjobb / Mölndal
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Medical Scientists are a resource for the Product Team, as physician-delegates working synergistically with physicians in the project as an expert in medical scientific aspects of the drug and it?s development. Accountabilities are broad and will depend upon the exact phase of development, though a core accountability is the medical & scientific support for the development and maintenance of the non-AZ sponsored clinical trial strategy. Additional physician-delegate tasks include the set-up, conduct, reporting and regulatory submission of clinical trials, liaison with discovery, regulatory, clinical and commercial colleagues, input to regulatory documentation, external relationship management and review of literature pertaining to the product(s) under development.
These individuals must ensure that all project activities are undertaken to the highest ethical and safety standards and in compliance with GCP, regulatory & appropriate pharmaceutical code requirements.
The job-holder can expect to get broad international exposure to other functions involved in the drug development process within AZ, gaining an overview of how strategic direction is set and how decisions are made during drug development.
The role
Depending on the competence and experience of the Medical Scientist, and the needs of the specific project, they may take on tasks delegated by the project physician where appropriate:
Represent the Project/Product and indication area internally (global and marketing companies) and support externally as a medical scientific expert
Co-ordinate Therapeutic area leadership for regional/global investigator non-AZ sponsored study programs, as agreed with the physician .
Ensure and champion consistent medical & scientific aspects of the clinical study plans across the programme
Provide medical scientific leadership to data and safety reviews ensuring consistency throughout the process
Provide medical science support to specific studies when requested by the physician as appropriate
Represent AstraZeneca as a support for steering/organizing committees, investigator meetings and external product specific advisory boards for the Project/product
Guide aspects of the Clinical Development Plan (CDP) and Clinical Study protocols in keeping with the approved CDP and ensuring linkage of trial data to target product claims / profile.
Input medical scientific information to internal documentation such as risk management plans, Investigator Brochures and strategic planning documents
Support key contacts with opinion leaders, and help develop alliances as appropriate
Follow important developments and trends in the medical & scientific literature
Write and check content and quality of product related publications and input to development of publication strategy.
Minimum experience
Relevant Clinical or Biomedical Ph.D or relevant Pharmacy, Nursing, MSc/MRes degree with >3 years R&D drug development experience
>3 years clinical drug development or medical affairs experience within a pharmaceutical company environment
A degree of specialist knowledge of the medical and scientific activities related to a particular therapeutic area/indication and/or to an assigned project or product
A good understanding of more than one development function
A clear demonstration of behaviours of....
To read FULL JOBDESCRIPTION and TO APPLY, please visit
www.astrazeneca.se/karriär .
Publiceringsdatum2014-12-05Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2014-12-18
Ange följande referens när du ansöker: MOL000001LI
FöretagAstraZeneca Mölndal
AdressAstraZeneca Mölndal
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
MÖLNDAL
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Övriga kontaktuppgifterTelefonnummer: 031-7761000
Jobbnummer 2092530
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