Job Title: Manager, Clinical Regulatory Writing
Location: [Insert Location Here]
Career Level: D
Introduction to Role: Are you ready to lead a team in delivering high-quality clinical regulatory documents? As a Manager in Clinical Regulatory Writing, you will provide communications expertise, primarily focusing on document development with occasional contributions to communication strategy at the program level. You will also play a key role in improvement projects, driving critical communication excellence to achieve successful submissions and approvals.
Accountabilities:
Clinical Regulatory Document Development:
Lead the authoring and timely delivery of high-quality clinical regulatory documents such as CSPs, CSRs, IBs, Module 2.7 submission documents, briefing documents, pediatric plans, regulatory responses, and specific documents supporting established brands.
Ensure that regulatory, technical, and quality standards are met and that relevant processes and best practices are applied throughout document development.
Balance multiple tasks across several drug projects, ensuring priorities are met.
Drive the clinical interpretation of data and information, condensing it into clear, concise, and accurate messages that meet customer information requirements.
Document Review & Collaboration:
Provide critical review of documents for correctness, clarity, completeness, and compliance with applicable regulations and standards.
Proactively collaborate with other functions during document development, including external service providers/contractors, as needed.
Join the clinical delivery team to support project communications, set communication standards, and promote quality and efficiency across projects.
Continuous Improvement & Leadership:
Strive for continuous improvement and operational excellence from a communications leadership perspective.
Represent Clinical Regulatory Writing on drug and non-drug projects, as required, and contribute to discussions on communication standards and improvements.
Work independently while receiving guidance and support from senior team members.
Essential Skills/Experience:
Life Sciences degree in an appropriate discipline.
Experience in medical communications and regulatory writing.
Strong communication and leadership skills.
Knowledge of technical and regulatory requirements for clinical regulatory documents.
Desirable Skills/Experience:
Advanced degree in a scientific discipline (Ph.D.).
Experience in medical writing within the pharmaceutical industry and a strong understanding of communication development in projects.
Work Model:
Minimum of three days per week in-office, with flexibility to accommodate individual needs.
About AstraZeneca: At AstraZeneca, we are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve breakthroughs. Our inclusive environment encourages collaboration with academia, biotechs, and industry experts to create swift impacts on disease. We offer varied opportunities for lifelong learning and career development while working on pioneering projects that have never been done before.
Ready to make an impact? Apply now to join our team!
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