Documentation Specialist- Clinical Pharmacology

Job Title Documentation Specialist- Clinical Pharmacology Safety Science Introduction to role Are you ready to dive into the world of clinical pharmacology and safety science As a Documentation Specialist you ll play a pivotal role in supporting regulatory submissions and reports within the Clinical Pharmacology and Quantitative Pharmacology CPQP department Your expertise will guide project teams through the technical requirements of clinical submissions ensuring compliance and excellence throughout the product lifecycle You ll be at the forefront of building clinical regulatory documents and submissions handling compliance in the AZ Regulatory Document Management system ERV and providing functional training and support Are you prepared to make a difference Accountabilities With general supervision you ll chip in to the preparation and compilation of regulatory submissions ensuring timeliness and quality within the following areas - Generate quality and clinical basic structures and content for regulatory submissions and documents - Apply relevant regulatory-authority compliant document naming conventions - Import and create documents for regulatory submissions including referenced literature and reference lists - Edit submission documents including cross-referencing citations creating abbreviations lists and formatting data tables - Ensure submission readiness conformance with house-style AstraZeneca s submission ready standards and regulatory agency requirements - Format Word documents perform PDF editing and ensure navigable submission documents - Give to the preparation and maintenance of submission document templates - Participate in project teams related to deliverables standards or harmonization within the team scope - Administer and provide end-user support for tools used within Biopharmaceutical Development including ERV Document Management System Essential Skills Experience - Bachelor s degree or equivalent industry-relevant experience - Awareness of basic principles of GXP and ICH International Conference on Harmonization - Basic understanding of CTD Common Technical Document content and formatting standards - Proficiency in Microsoft Office - Experience working within validated electronic document management systems - Familiarity with working within SharePoint - Basic knowledge of information management and document management tools - Proficient in the English language - Excellent written and verbal skills English Desirable Skills Experience - 1-2 years of industry experience in validated electronic document management systems - Knowledge of the basic principles of the drug development process - Basic understanding of principles of CFR21 part 11 requirements and other global standards - Experience with Adobe Acrobat and related ISI tools e g ISI toolbox - Experience as SharePoint site owner - Good social skills and ability to establish relationships - Strong communication skills with all levels of the organization - Ability to deal with ambiguity and changing priorities - Good attention to detail - Able to follow written standards procedures and processes When we put unexpected teams in the same room we ignite 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 curiosity and courage exploring new scientific frontiers to tackle some of the world s most complex diseases Our commitment to innovation is motivated by a passion for science empowering us to make bold decisions without fear of failure We collaborate seamlessly across diverse teams leveraging global knowledge to create impactful solutions With opportunities for lifelong learning and career growth AstraZeneca is where you can truly make a difference in patients lives Ready to embark on this exciting journey Apply now to join our team Date Posted 09-Jun-2025 Closing Date AstraZeneca embraces diversity and equality of opportunity We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills We believe that the more inclusive we are the better our work will be We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics We comply with all applicable laws and regulations on non-discrimination in employment and recruitment as well as work authorization and employment eligibility verification requirements