Senior Medical Communications Scientist
AstraZeneca / Undersköterskejobb / Göteborg
2017-08-16
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Do you have strong experience in regulatory medical writing?
Are you keen to provide expert communications leadership to the drug projects of a world-leading biopharmaceutical company?
At AstraZeneca, we need a Senior Medical Communications Scientists to join us at our research base in Gothenburg, Sweden. As a Senior Medical Communications Scientists you'll thrive in a culture of scientific excellence and have a close collaboration with colleagues in Cambridge, UK where we are investing in a new, state-of the-art Global R&D Centre; and Gaithersburg in the US.
Main duties and responsibilities
We pride ourselves on communicating evidenced-based product knowledge in a way that is credible, consistent and compliant. You'll lead the authoring of clinical-regulatory documents for MAA/NDA submission packages.
You will provide expert communications leadership to drug projects and drive strategic medical writing, advocating communications excellence in your team as you lead the efficient planning and authoring of clinical submissions. You will provide strong partnership with vendor medical writers to ensure delivery to time, cost and quality.
To be a Senior Medical Communications Scientist, you should want to move on from writing study-level documents to authoring more complex documents and submissions, taking on more strategic responsibilities and leading global authoring teams.
Accountabilities
* Lead development of the submission communication strategy for a new product, liaising with senior project staff
* Prospectively develop a storyboard for the submission and identify how the proposed prescribing information will be supported
* Lead the authoring of clinical documents for the NDA and MAA
* Author the most complex and important documents (eg, Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees)
* Lead a team of medical writers (internal and external) to deliver
* Ensure alignment of clinical submission documents with the proposed prescribing information
* Represent medical writing on the high-level, cross-functional submission team
* Collaborate with the medical writing team leader to develop resourcing strategies
* Develop and implement new best practices in communication and submission development
* Train and develop less experienced Medical Communication Scientists
Minimum Requirements
* Bachelor's degree in the life sciences, preferably with an MSc or PhD
* Experience within the pharmaceutical/medical industry/CRO
* Broad working knowledge of the clinical drug development process with experience in integrating information from all phases of clinical development into clinical-regulatory documents/submissions
* Ability to work well with vendors
* Comprehensive knowledge of current regulatory guidelines relating to regulatory communications
* Excellent communication skills
* Consistent display of ability in project management, thinking (conceptual, analytical and integrative), influencing and team working. Flexibility in adapting to changing circumstances or new information
* Willingness to undertake domestic and international travel as required by the project
If you are interested, apply now!
For more information about the position please contact: Christina Branting-Ekenbäck at +46 317762523.
Welcome with your application no later than September 13th, 2017.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2017-08-16ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2017-09-13
Ange följande referens när du ansöker: R-012402
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
katinka.larssen@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 3644647
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