Associate Principal Medical Communications Scientist
AstraZeneca AB / Kemistjobb / Göteborg
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Do you have experience in regulatory writing within the pharmaceutical area? Would you like to apply your expertise to make an impact at a company where we work together across global boundaries to turns ideas into life changing medicines? If so, we welcome you to join us at AstraZeneca.
We are looking for an Associate Principal Medical Communications Scientist to join a great team in Gothenburg, Sweden, who wants to play a part in our everyday work to make a difference for our patients. This is an exciting opportunity to author complex documents and submissions, take on strategic responsibilities and lead global authoring teams.
Our critical, core drug development expertise is at the heart of our three vibrant scientific centres in Gothenburg (Sweden), Cambridge (UK) and Gaithersburg (US). Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines.
Main Duties and Responsibilities
As an Associate Principal Medical Communications Scientist (MCS), you will provide expert communications leadership to late stage drug projects and drive strategic medical writing, advocating communications excellence in your team. The MCS ensures that NDA/BLA/MAA/JNDA/CN/ROW clinical documents align with project strategies, meet regulatory requirements and adopt best communications practices.
Accountabilities as MCS:
* Lead development of the clinical 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
Essential Requirements
We need you to have:
Solid experience in writing regulatory documents at study-level (eg, Clinical Study Reports), with a good understanding of pharmaceutical drug development. You will be ready to progress authoring more complex documents such as regulatory submissions within a global, strategic role.
As well as:
* MSc or PhD within Life Science or equal education
* Demonstrated regulatory writing experience gained within the pharmaceutical/medical industry/CRO.
* Willingness to undertake domestic and international travel as required by the project.
A desirable requirement is that you have CTD Submission experience.
If this sounds like the challenge for you - apply today!
We need your application no later than 11th November 2019.
For questions about the position please contact hiring manager Christina Branting-Ekenbäck at Christina.Branting- or +46317762523.
Additional information about our fantastic city and site:
Our Gothenburg site:
https://www.astrazeneca.com/our-science/gothenburg.htmlLife in Gothenburg:
https://www.movetogothenburg.com/Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-10-15ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-11-05
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-063365".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 4886103
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