Associate Director, Clinical Regulatory Writing, Vaccines & Immune Therapies
The Vaccine & Immune Therapies (V&I) unit has been created with the ambition to develop and deliver vaccines and antibodies that transform our ability to prevent and treat infectious disease. The creation and growth of this unit reflects AstraZeneca’s strong dedication to advance our ground-breaking science for the benefit of patients worldwide.
We are now recruiting an AssociateDirector, Clinical Regulatory Writing (CReW). In this role, you will provide strategic leadership and communications expertise to our vaccine and antibody programs. You will author clinical-regulatory documents, provide critical review to achieve high quality standards, and represent the skill on drug and non-drug projects.
- Independently lead clinical regulatory writing activities across a sophisticated portfolio of work.
- Author complex 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 critical communications to leadership on 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 (cSCS).
- Lead internal/external authoring teams and provide a positive relationship 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 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.
- An advanced degree (Master’s Degree or equivalent) in a scientific field or appropriate subject area.
- At least 3 years of established experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or CRO environment.
- Understand drug development and communication process from development, launch, and life cycle management.
- Ability to lead large, teams with varied strengths.
- In depth knowledge of the technical and regulatory requirements related to the role.
- Excellent verbal and written communication skills in English.
- Flexibility in adapting to changing circumstances or new information.
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 align with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
This opportunity is available at our Barcelona (Spain), Mississauga (Canada), Gaithersburg, MD (USA), Waltham, MA (USA), or Gothenburg (Sweden) locations. We expect employees to be on-site for a minimum of three days per week and are therefore unable to offer remote based working.
Where can I find out more?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
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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 authorisation and employment eligibility verification requirements.