Director, Clinical Regulatory Writing, Vaccines & Immune Therapies - Jobs in Mississauga

Job Description

Director, Clinical Regulatory Writing, Vaccinesamp; Immune Therapies (V amp;I)The Vaccineamp; Immune Therapies (V amp;I) unit has been built 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 #39;s strong dedication to advance our ground-breaking science for the benefit of patients worldwide.We are now recruiting a Director, Clinical Regulatory Writing (CReW). In this role you will provide authoritative leadership in one or several of our vaccine or antibody programs and partner with senior leaders to define and own the global communications strategy. You will be an authority of clinical regulatory writing activities for cross functional teams and external vendor partners.Director CReW advocates and develops gold standards for document and accelerated submission delivery, represents CReW in business process optimization and improvement initiatives, and supports the mentorship of internal talent.What You #39;ll DoAs a leader in V amp;I CReW you will be encouraged to:

• Provide experienced leadership to deliver submission communication strategies and drive the authoring of large clinical submission packages and other complex clinical documents that are aligned with project development plans, regulatory requirements, and communication standards.
• Build robust clinical arguments through strong analytical and communications skills and critically evaluate clinical trial designs.
• Be a proactive, independent, and innovative leader of large, sophisticated teams.
• Delegate and empower other internal and external writers, and ensure relevant regulatory, technical, and quality standards are achieved and the appropriate processes and standards are applied.
• Effectively influence customers and colleagues at the highest levels of a program to establish best communications practices.
• Be steadfast in the pursuit of excellence and driven to improve standards across the business. Recognize opportunities and spearhead improvement initiatives at the TA or company-wide level.
• Support the growth and development of the V amp;I CReW community by actively mentoring less experienced writers and serving as a role model for the function.
• Manage and prioritize multiple projects in parallel, often working under accelerated timelines to deliver.

Minimum Qualifications:

• An Advanced Degree (Master #39;s Degree or equivalent) in a scientific field or appropriate subject area.
• At least 6 years of established experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or CRO environment.
• Broad cross-functional understanding of the drug development process from scientific, technical and business perspectives.
• Experience in leading large, complementary teams.
• Excellent verbal and written communication skills in English.
• Conceptual and strategic problem-solving ability with strong networking and influencing skills.
• Flexibility in adapting to changing circumstances or new information.

Desirable Qualifications:

• Ph.D in a scientific field with 8 years of established expertise.
• Extensive knowledge of the latest technical and regulatory expectations.
• Excellent organizational, analytical, decision-making, and interpersonal skills to lead sophisticated projects simultaneously and to handle constantly evolving priorities.

Why AstraZenecaAt 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 #39;re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested Come and join our journey.This opportunity is available at our Barcelona (Spain), Mississauga (Canada), Gaithersburg, MD, 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 moreOur Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/hl=en#V amp;IDate Posted12-Jan-2024Closing DateOur mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.