Senior Medical Communications Scientist (Regulatory Medical Writer)

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POST DATE 9/2/2016
END DATE 10/23/2016

AstraZeneca Pharmaceuticals LP Gaithersburg, MD

Company
AstraZeneca Pharmaceuticals LP
Job Classification
Full Time
Company Ref #
360561
AJE Ref #
576067005
Location
Gaithersburg, MD
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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Do you have strong experience in regulatory medical writing? br br Are you keen to provide expert communications leadership to the drug projects of a world-leading biopharmaceutical company? br br 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. br br Main duties and responsibilities br br 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. br br 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. br br 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. br br Accountabilities br br * Lead development of the submission communication strategy for a new product, liaising with senior project staff br * Prospectively develop a storyboard for the submission and identify how the proposed prescribing information will be supported br * Lead the authoring of clinical documents for the NDA and MAA br br * Author the most complex and important documents (eg, Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees) br * Lead a team of medical writers (internal and external) to deliver br * Ensure alignment of clinical submission documents with the proposed prescribing information br * Represent medical writing on the high-level, cross-functional submission team br * Collaborate with the medical writing team leader to develop resourcing strategies br * Develop and implement new best practices in communication and submission development br * Train and develop less experienced Medical Communication Scientists