Director, Informed Consent Content and Framework Development

at  AstraZeneca

WHY JOIN US?

At AstraZeneca, we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. With an ambitious goal of delivering 20 new medicines by 2030, there is no better place to make a difference in medicine, for patients, and in society.
Join us on this exciting journey to pioneer the future of healthcare. Our inclusive culture champions diversity and collaboration, and we are always committed to lifelong learning, growth, and development. As part of our team, you’ll contribute to groundbreaking advancements that will shape a healthier future for people everywhere. Be a catalyst for change at AstraZeneca, where your work will have a real impact on improving people’s lives.
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 head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
About the Opportunity:
AstraZeneca is revolutionizing patient consent data management through an R&D Transformation Programme. We aim to create a patient-friendly, compliant, digital, and efficient modular consent system. This will empower patients to make informed decisions about clinical trial participation while enhancing data and sample re-use and optimizing consent development timelines.
The Director, Informed Consent Content and Framework Development (Workstream Lead), leads and improves consent content and frameworks to create concise, compliant consent forms. They collaborate with stakeholders to gather local and global regulations, maintaining them in a library for efficient form delivery.
Within the Informed Consent Transformation Programme, the Workstream Lead provides strategic expertise and guides process transformation, reporting to the Programme Lead. As a recognized expert, they serve as the main contact for related queries.

Accountabilities:

• Lead the management and continuous improvement of consent content and modular frameworks.
• Ensure the creation of simpler, shorter informed consent forms that comply with regulations.
• Work with internal and external customers and stakeholders to maintain local regulations and requirements.
• Maintain a library of local regulations and country-specific requirements for effective delivery of consent forms globally and locally.
• Develop and manage content components and document frameworks.
• Coordinate content and framework approvals through Governance Committees with cross-functional representatives.
• Support the creation of Work Instructions and Job Aids for the centralised service team.
• Ensure effective communication of information.
• Provide high-quality training for new team members on operational processes, systems, and centralised services.
• Offer strategic expertise and guidance to the Programme lead on transformative processes and workstream development.

Essential Skills and Experience:

• Bachelor’s degree in a relevant discipline
• Significant experience in Global Study Management (3-5 years) within a pharmaceutical or clinical background
• Capabilities to manage through change
• Ability to work collaboratively, motivate and empower others to achieve objectives
• Commitment to patient centricity
• Excellent knowledge of spoken and written English
• Strong business communication, stakeholder management, and presentation skills
• Strong knowledge of ICH-GCP for informed consent requirements
• Experience in developing master consent forms that meet regulatory requirements
• Strong influencing, negotiation, critical thinking, and conflict management skills
• Well-developed organizational and interpersonal skills
• Demonstrated ability to problem-solve and transfer knowledge
• High-level working knowledge of global informed consent regulations

Desirable Skills and Experience:

• Advanced degree within field
• Professional certification
• Clinical study delivery operational experience
• Project management experience
• Site Study Co-ordinator experience supporting the administration of informed consent
• Experience working in Platform or Basket trials
• Previous experience in a similar transformation role
• Previous experience of successfully implementing cross-enterprise change

Please refer the Job description for details