Director, Clinical Regulatory Writing

AstraZeneca

  • Cambridge
  • Permanent
  • Full-time
  • 17 hours ago
Job Title: Director, Clinical Regulatory WritingLocation: Cambridge, UK
Salary: CompetitiveIntroduction to role:Are you ready to lead the charge in transforming breakthrough science into life-altering solutions? As the Director of Clinical Regulatory Writing, you'll be at the forefront of driving strategic communication excellence to achieve successful submissions and approvals. Our team provides expert communications leadership to drug projects, crafting clinical-regulatory documents that align with project strategies and regulatory requirements. You'll be engaged in multiple high-priority programs, acting as both a leader and coach, advocating for the team and fostering an environment of productivity and engagement. Your role will involve developing communication strategies, optimizing document delivery, and supporting talent growth within our core therapeutic areas across all phases of clinical development.Accountabilities:
  • Provide expert leadership across a group of submissions or programs, overseeing the communication strategy.
  • Drive the use and exploitation of information by sharing drug and disease-specific knowledge and experience across program and submission teams.
  • Identify commonalities and differences in communication strategy, content, and process across multiple programs or submissions, optimizing approaches.
  • Influence stakeholders at the highest levels of the organization to establish best communications practices.
  • Lead submission activities and author key documents within a program.
  • Review key submission documents for consistency of messaging.
  • Continuously develop best practices for the Clinical Regulatory Writing organization.
  • Represent Clinical Regulatory Writing on various improvement workstreams and external activities.
  • Drive resourcing strategy within area of accountability.
  • Support recruitment and onboarding activities for new members of the group.
Essential Skills/Experience:Minimum Master degree in Scientific discipline, PhD is strongly preferredProficiency at authoring/editing and managing the writing/review of multiple types of clinical regulatory documents and submissions outlined below:Thorough understanding of oncology drug development and knowledge of oncology end points is a mustClinical interpretation skills, stakeholder management skills,IND (briefing documents, clinical study protocols, paediatrics investigational plans, ph 1 and 2 CSR)NDA (ph 3 CSR, module 2 summary )Health authorities responsesProgram management experienceAbility to effectively communicate with stakeholders within AstraZeneca and beyond.Desirable Skills/Experience:Advanced degree in a scientific discipline (Ph.D).Experience in using AI tools for medical writingLine / team management experienceWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.At AstraZeneca, we are driven by science, success, and achieving our goals through innovative approaches. Our inclusive environment fosters collaboration across global teams, unlocking regulatory knowledge to bring life-changing medicines to patients efficiently. With a rich pipeline offering exposure to the complete drug delivery process, you'll have opportunities to take on new challenges and be an agent of change. We thrive on asking questions, trying new things, and developing modern approaches that minimize barriers for niche patient populations.Ready to make a difference? Apply now to join our dynamic team!So, what’s next?Complete your application before the below closing date.We welcome your application no later than 18th September 2025Where can I find out more?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=enAre you ready to make a difference? Apply today and join us in our mission to improve global public health!Date Posted 03-Sept-2025Closing Date 18-Sept-2025Our 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