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Location: Cambridge, England, United Kingdom
Job reference: R-000832
Posted date: Mar. 10, 2017

Senior Medical Communications Scientist (Regulatory Medical Writer)

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 Senior Medical Communications Scientists to join us at two of our worldwide research bases: Cambridge in the UK, where we are investing in a new, state-of the-art Global R&D Centre; and Gaithersburg in the US. In either location, you'll thrive in a culture of scientific excellence and collaboration.

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

Requirements

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.

Medical Communications Scientist
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.

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