Documentation Specialist- Clinical Pharmacology & Safety Science

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!