This is a temporary contractor opportunity at Novartis 

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! 

This role is offered through Magnit Global, who, if selected, will be your employer. If your services are retained, you will be assigned to provide services to Novartis as the end client. This is not an offer of employment with Novartis. If you are selected for this Temporary/External opportunity, you will not be an employee of Novartis and will not be eligible for any Novartis employee benefits or incentives.

 Ready to work with/through Magnit at Novartis? Please read on…

Major accountabilities:

• To author, review and/or independently manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Risk Management Plans (RMP), complex CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (e.g., Briefing Books, answers to questions).
• Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
• Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions.
• Documentation expert in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines.
• Provide content and strategic expertise for clinical portions of the CTD.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Distribution of marketing samples (where applicable).

Key performance indicators: 

• Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards
• Customer / partner/ project feedback and satisfaction 
• Adherence to Novartis policy and guidelines

Minimum Requirements: 

• Work Experience: 
• Functional Breadth.
• Project Management.
• Collaborating across boundaries.
• Operations Management and Execution.
• Representing the organization.

Skills: 

• Clinical Research.
• Clinical Trials.
• Detail Oriented.
• Medical Writing.
• People Management.
• Project Management.
• Regulatory Compliance.
• Safety.
• Languages : English.

Workload: 35 hours/week
Type: Hybrid (3 days/week onsite)
Required start date: June 2026
Contract: until 25 December 2026
Inside IR35

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?

EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accommodation: 
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at [email protected].