Associate Director, R&I Clinical Regulatory Writing (CReW)

About the Company

Responsibilities

• ● Independently manage clinical regulatory writing activities across a portfolio of work.
• ● Author clinical-regulatory documents within a program by ensuring that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied.
• ● D rive the development of the clinical Submission Communication Strategy.
• ● Lead internal/external authoring teams and provide strong partnership 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 information requirements.
• ● Be a strategic thinker and demonstrate strategic review capabilities.
• ● Proactively collaborative with other functions at the program level.
• ● Support the development of others in Clinical Regulatory Writing.
• ● Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the Clinical Regulatory Writing function on drug and non-drug projects, as required . Minimum Qualifications:
• ● A Bachelor's degree
• ● At least 5 years of e xperience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or Contract Research Organization environment.
• ● Understanding of the drug development process from development through life-cycle management .
• ● Excellent verbal and written communication skills in English.
• ● In depth knowledge of the technical and regulatory requirements related to the role.
• ● Flexibility in adapting to changing circumstances and latest information . Desirable Qualifications:
• ● Advanced degree in a scientific discipline ( Ph.D . ).
• ● Why AstraZeneca
• ● At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
• ● So, what's next