OBS! Ansökningsperioden för denna annonsen har
Do you have experience in regulatory writing within the pharmaceutical area, enjoy flexible working and leading the authoring of clinical documents for the NDA and MAA? 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 a Associate Director/Senior 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.
What you’ll do:
As a 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. The role will afford you flexibility in ways of working.
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 in the role:
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.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work and bringing unexpected teams together!