Summary
About the Role
- Provide a robust framework to oversee the management, compilation and timely dispatch of high quality, regulatory compliant global HA submissions.
- Provide advise to project teams on technical submission requirements.
- Stay on the pulse of evolving submission related global Health Authority requirements, ensuring NVS is influencing and shaping policy in this area and building strategies to proactively prepare the organization for the future.
- Continually develop and implement enhanced compliance /process efficiencies to global submission preparation standards, strategies and related procedures/tools.
- Ensure global cross-functional business/IT/external partners adopt and continually adhere to the established submission/document standards, policies and operating procedures.
- Oversee the management and support of all Regulatory Systems and tools, keeping them updated, compliant and validated.
- Own and ensure a controlled documentation system/record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
- Ensures compliance to the requirements/guidances from regulatory agencies.
- Assures adherence to procedures to classify and maintain records.
- May analyze and evaluate data, extract pertinent information, prepare abstracts and executive summaries of material searched.
- May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.
- May execute people management role, with responsibility for a specific function/technical area.
- Establishes operational objectives and work plans, and delegates assignments to subordinates.
- Senior management reviews objectives to determine success of operation.
- Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
- Contributes to and often leads the development of departmental goals and objectives.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
- Adherence to Novartis policy and guidelines -Project and stakeholder feedback
Work Experience:
- Strategy Development.
- Major Change.
- People Challenges.
- Managing Crises.
- Collaborating across boundaries.
- Operations Management and Execution.
- Project Management.
- Data Analysis.
- Documentation Management.
- Lifesciences.
- Proactivity.
- Process Improvement.
- Project Management.
- Regulatory Compliance.
- 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
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
TEst Hello
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
