At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. We are currently hiring for a Senior Medical Communications Scientist 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.
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 the clinical submission documents
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
Bachelor's degree in the life sciences, preferably with an MSc or PhD.
Minimum of two years' 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.
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.