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Arbetsbeskrivning
Are you an inclusive Leader with expertise in Clinical Regulatory Medical Writing? Would you like to apply your knowledge to impact the development of medicines to patients? Then AstraZeneca might be the one for you!
Development Operations is here to deliver science through a wide range of specialist expertise, operational excellence and data driven innovation. These enable us to drive extensive clinical trial programmes from design to regulatory submission and approval. Providing the key connection between science and commercialization, we deliver trials and submissions to the highest standards of quality, efficiency and ethics to thousands of patients globally.
Our global Medical Communications (MCs) group is present in Gothenburg - Sweden, Cambridge - UK and Gaithersburg - US. We are accountable for providing industry-leading, expert communications leadership across all phases of clinical development and across worldwide clinical submissions and approvals. MCs ensures that clinical regulatory documents align with project strategies, meet regulatory requirements and embrace the best communications practices. The group has a clear vision to drive strategic communications excellence to achieve successful submissions and approvals, ultimately playing a key part in us achieving our goal of delivering safe medicines to the patients most in need.
What you'll do
As Senior Director in Medical Communications, you will lead a team of Medical Communications Scientists to provide strategic communications leadership in delivering global clinical submissions across the Late CVRM portfolio to achieve first-cycle approvals. You will be responsible for provision of internal and external resourcing strategies to ensure business goals are met. This includes maintaining and building relationships with multiple partners and external vendors. In this role, you will lead communications colleagues internally and externally in two or more regions and with multiple vendors. Furthermore, you are also responsible for successful delivery in line with quality, time and budget. You will lead a global team and based on your preferences, you can be based in Gothenburg - Sweden, Cambridge - UK or Gaithersburg - US.
We will rely on you to:
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Lead the implementation of Strategic Clinical Communications and drive input to the global clinical development strategy (from influencing study design, and from TPP to Label) from a communications perspective
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Support projects by providing strategic communications advice, influencing the development of communications to global business, clinical development and health authorities.
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Encourage and develop colleagues to continuously adopt world class writing practices
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Lead and develop your team by supporting and influencing their development and performance
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Manage external vendors to support high quality delivery to the portfolio
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Collaborate within own area on manager accountabilities to ensure alignment and global consistency
Essential for the role
To succeed in this exciting role, you will be recognized externally as an inspiring Leader and specialist within Medical Writing, with significant confirmed experience managing, leading and developing teams in this area. Your validated leadership and mentoring skills will be evidenced by your track record of driving performance within your teams to accomplish goals. You are an excellent communicator who comfortably influence and communicate with key partners.
You hold a Bachelor's degree, at a minimum, in a relevant scientific field, which is further complemented by experience from the pharmaceutical or biotech industry. We expect you to have an extensive knowledge of the clinical drug development process and experience of the TAs related to AstraZeneca's products.
Furthermore, we expect you to have:
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Significant experience of authoring clinical regulatory submission and leading writing activities for NDA/MAA submissions, including experience of Regulatory interactions to support or defend the commercial label or drug approvals
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Shown experience of advising and leading complex medical communications projects
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Proven ability to work with vendors to deliver to budget, quality, time and cost
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Willingness to travel domestically and internationally
Desirable for the role
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MSc or PhD in relevant scientific field
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Authoritative reputation within the business and industry
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Extensive knowledge of the latest technical and regulatory expectations
Why AstraZeneca?
Work with curious minds in an inclusive culture. Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment. Here all doors are open, and every voice is heard. From working side-by-side with academia to innovating with biotech - we are forever expanding our horizons.
So, what's next!
Are you ready to bring new ideas and fresh thinking to the table? Great! We have one seat available, and we hope it's yours.
We welcome your application, no later than April 22nd, 2021.
Read more about our three strategic R&D centres: https://www.astrazeneca.com/r-d/our-strategic-r-d-centres.html
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