Associate Director, Clinical Regulatory Writing at AstraZeneca

Posted in Other 14 days ago.

Location: Gaithersburg, Maryland

Job Description:

Are you passionate about Regulatory Writing? Would you like to have an impact on patients' lives and contribute to eliminate cancer as a cause of death? If so then join us!

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.

We are now recruiting an Associate Director, Clinical Regulatory Writing (CReW). The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company's core therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals.

The Clinical Regulatory Writing Associate Director is expected to:

  • Independently lead clinical regulatory writing activities across a complex portfolio of work.

  • Author the most sophisticated clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and standard methodology are applied.

  • As part of a clinical delivery or submission team, provide crucial communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.

  • When acting as a submission lead, drive the development of the clinical Submission Communication Strategy.

  • Lead internal/external authoring teams and provide positive relationships with vendor medical writers to ensure delivery to time and quality.

  • Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements.

  • Be a strategic problem solver and demonstrate strategic review capabilities.

  • Proactively collaborative with other functions at the program level.

  • Support the development of Clinical Regulatory Writing Managers.

  • Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required.

Minimum Qualifications:

  • Bachelor's degree in Life Sciences in an appropriate subject area

  • Minimum of 5 years' experience

  • Significant medical writing experience in the pharmaceutical industry or CRO.

  • Ability to advise and lead communication projects.

  • Understand drug development and communication process from development, launch through life cycle management.

  • In depth knowledge of the technical and regulatory requirements related to the role.

Desired Qualifications:

  • Advanced degree in a scientific field (Ph.D.)

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what's next!

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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