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 Title: Nonclinical Document Specialist
Introduction to role:
Are you ready to embrace new and varied opportunities to develop and learn? As a Nonclinical Document Specialist, you'll be part of the Nonclinical Submission group, responsible for ensuring the technical quality and timely delivery of all nonclinical submissions. You'll provide expert advice on nonclinical submission technical requirements to project teams, including both internal and external partners, throughout the lifecycle of a product. This is your chance to build nonclinical regulatory submissions for clinical trial and marketing applications in accordance with current standards and processes using agreed-upon tools. Are you ready to make an impact?
Accountabilities:
Your role will involve generating quality nonclinical structures and content for regulatory submissions, ensuring relevant regulatory-authority compliant document naming conventions are applied to components. You will import and create documents for regulatory submissions, including referenced literature and reference lists. 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 templates.
Essential Skills/Experience:
Expertise in using Document Management Systems gained in a pharmaceutical environment, e.g., Veeva Vault
Experience in understanding nonclinical dossier structures and advanced knowledge of common file formats and related publishing tools (e.g., ISI Toolbox, Adobe Acrobat, eCTDXPress)
Knowledge of regulatory authorities’ requirements on electronic submissions in several regions (e.g., US, Europe, etc.)
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
Experience with simplifying processes through automation (e.g., with Power Automate)
Experience working in cross-functional, global project teams
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 (house-style), and related suites
Familiarity with working within SharePoint
Basic knowledge of information management and document management tools and best practices
Bachelor’s degree or equivalent industry-relevant experience
Desirable Skills/Experience
3-5 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
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.
At AstraZeneca, we fuel ambition and break new ground with our growing BioPharmaceuticals pipeline. Our forward-looking approach allows us to see the world through a different lens, connecting science with technology to find solutions that impact patients' lives. We thrive in a vibrant environment filled with diversity that reflects the variety of patients we serve. Here, everyone is empowered to speak up and share ideas, fostering an inclusive atmosphere where alternative perspectives push our thinking further. With ample opportunities for continuous learning and career growth, AstraZeneca is committed to enhancing patient care for the future.
Ready to make your mark? Apply now and be part of our journey!
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.
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.
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.
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.
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.
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