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For Companies At a Glance
- Tasks: Lead strategic communication for clinical regulatory submissions and approvals.
- Company: AstraZeneca is a pioneering biotech firm committed to inclusive practices and innovative healthcare solutions.
- Benefits: Enjoy flexible working arrangements, competitive salary, and opportunities for professional growth.
- Why this job: Join a dynamic team making a real impact on global health through groundbreaking medicines.
- Qualifications: Master's degree required; PhD preferred, with experience in oncology drug development and regulatory writing.
- Other info: Work in a collaborative environment, with a focus on innovation and personal development.
The predicted salary is between 54000 - 84000 £ per year.
Job Title
Director, Clinical Regulatory Writing
Location
Cambridge, UK
Salary
Competitive
Introduction 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 preferred.
- Proficiency 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 must.
- Clinical interpretation skills, stakeholder management skills.
- Experience with IND (briefing documents, clinical study protocols, paediatrics investigational plans, phase 1 and 2 CSR).
- Experience with NDA (phase 3 CSR, module 2 summary).
- Experience with Health authorities responses.
- Program management experience.
- Ability 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 writing.
- Line / team management experience.
Working Environment
When 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.
Our Culture
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.
Next Steps
Ready to make a difference? Apply now to join our dynamic team! Complete your application before the closing date: 31st January 2026.
Contact Information
Are you ready to make a difference? Apply today and join us in our mission to improve global public health!
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Director, Clinical Regulatory Writing employer: myGwork - LGBTQ+ Business Community
Contact Detail:
myGwork - LGBTQ+ Business Community Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Clinical Regulatory Writing
✨Tip Number 1
Network with professionals in the clinical regulatory writing field, especially those who have experience at AstraZeneca or similar companies. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in oncology drug development.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements and submission processes for oncology drugs. Understanding the nuances of IND and NDA submissions will give you a significant edge when discussing your expertise during interviews.
✨Tip Number 3
Showcase your leadership skills by highlighting any previous experience in managing teams or projects. Be prepared to discuss how you've successfully influenced stakeholders and driven communication strategies in past roles.
✨Tip Number 4
Stay updated on the latest AI tools used in medical writing. Being knowledgeable about these technologies can set you apart from other candidates and demonstrate your commitment to innovation in the field.
We think you need these skills to ace Director, Clinical Regulatory Writing
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Director, Clinical Regulatory Writing position. Understand the key responsibilities and required skills, especially in clinical regulatory documents and oncology drug development.
Tailor Your CV: Customise your CV to highlight relevant experience in clinical regulatory writing and any leadership roles you've held. Emphasise your proficiency in authoring and managing clinical documents, as well as your understanding of oncology.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and how your background aligns with AstraZeneca's mission. Mention specific experiences that demonstrate your ability to lead communication strategies and influence stakeholders.
Highlight Your Skills: In your application, clearly outline your skills in stakeholder management, program management, and any experience with AI tools in medical writing. This will help you stand out as a candidate who can drive strategic communication excellence.
How to prepare for a job interview at myGwork - LGBTQ+ Business Community
✨Showcase Your Expertise in Oncology
Given the emphasis on oncology drug development, it's crucial to demonstrate your deep understanding of this field. Be prepared to discuss specific oncology endpoints and how they relate to regulatory writing. Highlight any relevant experience you have in this area.
✨Prepare for Stakeholder Management Questions
As a Director, you'll need to influence stakeholders at high levels. Anticipate questions about your experience in managing relationships and driving communication strategies. Use examples from your past roles to illustrate your ability to navigate complex stakeholder environments.
✨Demonstrate Leadership and Coaching Skills
This role involves leading and coaching teams, so be ready to discuss your leadership style and experiences. Share specific instances where you've successfully guided a team through challenges or fostered an environment of productivity and engagement.
✨Familiarise Yourself with AI Tools
With the mention of AI tools in the job description, it’s beneficial to show your familiarity with these technologies. Discuss any experience you have using AI in medical writing or other relevant applications, and be open to discussing how you can leverage these tools to enhance regulatory writing processes.
