Sumar
About the Role
Major accountabilities:
Accountable for electronically preparing, publishing, quality reviews, validation, dispatch & archiving activities related to clinical deliverables and global regulatory submissions.
Produce high quality, clinical deliverables, and global submission outputs per agreed timelines and in compliance with worldwide HA requirements, internal working practices and guidelines.
Act in a global capacity, and partner with various cross-functional stakeholders (e.g., Regulatory Affair Managers, Regulatory CMC Managers, Clinical Trial Leads, Nonclinical Managers, Safety and Quality associates as well as with Clinical Submission Managers, RA Operations Submission Managers and a publishing team located in multiple regions (e.g., US, EU, UK and India)
Support the implementation of new technology, tools, and processes, contribute to ongoing initiatives and training, and help identify continuous improvement opportunities.
Support submission resource planning activities, as required.
Your Experience:
Bachelor's degree in life sciences or relevant discipline.
Clinical Report and Global Submission dossier publishing/compilation experience in the pharmaceutical or related industry.
Experience with electronic clinical document publishing standards/formats, electronic and global regulatory submission publishing standards/formats (e.g. eCTD, EU CTR).
Working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools
Familiarity with global Clinical and Regulatory HA requirements (e.g., FDA, ICH, EMA, MENA region, CH, MHRA)
Strong interpersonal and project management skills, and experience working in a complex, global cross functional organization.
Highly motivated, organized, and detailed oriented team player
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Ability to readily adjust to change in a fast-paced environment and multitask.
Positive attitude and ability to effectively collaborate with peers, stakeholders, cross-functional colleagues in a global team environment.
Strong technical skills
Strong communication and business writing skills.
Fluency in English
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?: https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
