Skip Navigation

Job Title

Job category

Science

Search jobs by matching your skills with LinkedIn

Sign up for job alerts

Or search again

Search by city

Location:
Cambridge, England, United Kingdom
Job reference: R-047650
Posted date: Mar. 25, 2019
Apply

Associate Principal Medical Communications Scientist (Strategic Regulatory Writer)

Location: Cambridge, UK

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity, even in the most difficult situations because we are committed to doing the right thing.

Our critical, core drug development expertise is at the heart of our three vibrant scientific centres in Gothenburg (Sweden), Cambridge (UK) and Gaithersburg (US).  This is an exciting period for us, as well as for those poised to join 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.

We are looking for an Associate Principal Medical Communications Scientist to join us in Cambridge, UK. This is an exciting opportunity to author complex documents and submissions, take on strategic responsibilities and lead global authoring teams.

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

  • 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

Requirements

Essential

To join us as a MCS, you should have solid experience writing regulatory documents at study-level (ie, Clinical Study Reports), with a good understanding of pharmaceutical drug development. You will be ready to progress to authoring more complex documents such as regulatory submissions within a global, strategic role.

In addition, you will have:

  • Bachelor's degree in the life sciences, preferably with an MSc or PhD.
  • Demonstrated regulatory writing experience gained within the pharmaceutical/medical industry/CRO.
  • Willingness to undertake domestic and international travel as required by the project.

Desirable

  • CTD Submission experience

This role is available at a variety of career levels dependent on experience.

Competitive salary and benefits.

Closing date for applications: 31st May 2019

Next Steps -- Apply today!

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.

Apply
Associate Principal Medical Communications Scientist (Strategic Regulatory Writer)
Clinical Development

AstraZeneca in the UK

Our 6,700-strong UK workforce is based across seven sites in the UK, including our new research facilities and global corporate headquarters in Cambridge. The Cambridge Biomedical Campus (CBC) is globally renowned as a leading centre of research, education and patient care. For AstraZeneca, the campus is the perfect environment in which to foster a vibrant culture of open innovation and collaboration.

Learn more

Sign up for job alerts

If you would like to sign up for email job alerts for future roles with AstraZeneca or MedImmune you can do so using the form below. We will only use the details you provide below to inform you about future vacancies that match your search criteria if and when they become available. The details you provide on this page will not be used to send unsolicited communication and will not be sold to a third party.

 

You can select as many categories and locations as you wish.

Interested InSelect a job category from the list of options. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

  • Clinical Development, Cambridge, England, United KingdomRemove