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| Job Location | Cambridge |
| Education | Not Mentioned |
| Salary | Competitive salary |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent, full-time |
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 turn ideas into life changing medicines If so, we welcome you to join us at AstraZeneca.We are looking for someone to join our team in Cambridge UK, 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, tackle 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 You will provide 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 embrace best communications practices.Accountabilities as MCS:You will lead development of the clinical submission communication strategy for a new product, liaising with project staff, prospectively develop a storyboard for the submission and identify how the proposed prescribing information will be supported. Youll lead the authoring of clinical documents for the NDA and MAA and author the most complex and meaningful documents (eg, Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees). Also, you will manage a team of writers (internal and external) whilst ensuring alignment of clinical submission documents with the proposed prescribing information and represent medical writing on the high-level, cross-functional submission team. Essential Requirements