Nonclinical Document Specialist

Posted date Jul. 21, 2026

Contract type Full time

Job ID R-256771

Why choose AstraZeneca India?

Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare.

The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports.

Who do we look for?

Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.

Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.

Success Profile

Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.

Tech innovators

Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives.

Ownership takers

If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level - with unrivalled support when you need it.

Challenge seekers

Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks.

Proactive collaborators

Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best.

Responsibilities

Job ID R-256771 Date posted 07/21/2026

Job Title: Nonclinical Document Specialist

Global Career Level: C

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work.

ABOUT THE ROLE

Introduction to role

Are you ready to embrace new and varied opportunities to develop and learn? As a Nonclinical Document Specialist, you’ll work as a member of the Nonclinical Submission group with accountability for the technical quality, repository and delivery of all nonclinical data (primary raw data and critical biological specimens) and data for non-clinical submissions. You will coordinate and manage data archival, provide advice on nonclinical submission technical requirements to project teams, including internal and external partners, throughout the lifecycle of a product. This is your chance work with data for nonclinical regulatory submissions for clinical trial and marketing applications in accordance with current standards and processes using agreed upon tools.

Accountabilities:

For primary raw data, the role would focus on supporting archive-related processes, managing requests, coordinating urgent requirements, and maintaining effective communication across stakeholders, ensuring that all relevant forms, chain of custody requirements, and internal delivery arrangements are properly managed through operational processes. The role also includes oversight of archival data management within the database, supporting the accuracy, completeness, and consistency of records held in internal databases or other relevant archive management systems. For non-clinical documents, your responsibilities will also include submission document editing, submission readiness conformance with house-style, AstraZeneca’s submission ready standards and regulatory agency requirements. You will also contribute to the preparation and maintenance of submission document content plans and templates.

Essential Skills/Experience:

Good understanding of records management, or document control principles, with the ability to apply these in a regulated or process-driven environment.

Experience of maintaining accurate records within archive or data management systems, with strong attention to detail and data quality, including accurate indexing, metadata quality, traceability, and retrieval requirements.

Highly developed influencing skills and interactive communication when interacting with people at all levels and within teams

Demonstrated ability to set and manage priorities, resources, goals and project initiatives

Demonstrated strong written and verbal communication skills, with the ability to provide clear updates, manage queries professionally, and build effective working relationships across cross-functional, geographically dispersed global teams and matrix structures.

Awareness of basic principles of GXP and ICH (International Conference on Harmonization)

Basic understanding of CTD (Common Technical Document) content and formatting standards to ensure submission compliant documentation

Proficiency in Microsoft Office, particularly Microsoft Word and Excel (editing, data handling), and related suites

Familiarity with working within SharePoint

Experience with simplifying processes through automation (e.g., with Power Automate)

Experience working within validated electronic document management systems in a pharmaceutical environment, e.g., Veeva Vault

Bachelor’s degree or equivalent industry-relevant experience

Desirable Skills/Experience:

3-5 years of industry experience in validated electronic data 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 database tools

Experience in understanding submission dossier structures and advanced knowledge of common file formats and related publishing tools (e.g., ISI Toolbox, Adobe Acrobat, eCTDXPress)

When we put unexpected teams in the same room, we unleash 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.

Why AstraZeneca?

At AstraZeneca' Biopharmaceuticals R&D, we are part of the olution, turning our drug development trategies into reality. We work at all tages of development to translate our ife-changing cience into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different kills and experiences. Our differences enable s to explore new ideas and ways of doing things. It keeps s on our toes and excited for what' next.

Where Can I Find Out More?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Call to Action:

Ready to make a difference? Apply today and be part of our journey to create life-changing medicines!

Date Posted

21-Jul-2026

Closing Date

26-Jul-2026

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.

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Reasons to Join

Thomas Mathisen

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Sales Representative Oslo, Norway

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Christine Recchio

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Sales Representative California, United States

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Stephanie Ling

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

Sales Representative Petaling Jaya, Malaysia

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

What we offer

We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you.

Lifelong learning

Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still.

Autonomy and reward

Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing - with performance-based rewards as part of the package.

Health and wellbeing

An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority.

Inclusion and diversity

Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.