Associate Director, Clinical Regulatory Writing at AstraZeneca

Posted in Other 4 days ago.

Location: Boston, Massachusetts





Job Description:

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.


Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our offices are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.


Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.


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:



  • Life Sciences degree in an appropriate subject area.


  • We require a 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.)




If this sounds like the type of organization where you would like to grow your career and make a real difference to patients then we would like to hear from you; apply today!



So, what's next!



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


Are you interested in working at AZ, apply today!


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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