At a Glance
- Tasks: Manage and author high-quality clinical documents that impact patient lives.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Gain valuable experience in a hybrid work environment with a focus on collaboration.
- Other info: Opportunity for growth in a dynamic and impactful industry.
- Why this job: Make a real difference in healthcare while developing your skills in a supportive team.
- Qualifications: Experience in clinical research and strong writing skills are essential.
The predicted salary is between 50000 - 60000 £ per year.
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.
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
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 directsourceproteam@prounlimited.com.
Signatory Business Partner employer: WillHire
At Novartis, we are dedicated to making a meaningful impact on human lives, and as a Signatory Business Partner, you will be part of a collaborative and supportive community that values innovation and excellence. Our hybrid work model promotes flexibility, allowing you to balance your professional and personal life while contributing to groundbreaking clinical research. With a focus on employee growth and development, Novartis offers a unique opportunity to engage in high-quality projects that directly influence patient outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Signatory Business Partner
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who have worked with Novartis or similar companies. A friendly chat can lead to insider info and maybe even a referral!
✨Tip Number 2
Prepare for the interview by knowing your stuff! Dive deep into Novartis' recent projects and their impact on healthcare. This shows you're genuinely interested and ready to contribute to their mission.
✨Tip Number 3
Practice makes perfect! Get a friend or mentor to do mock interviews with you. Focus on articulating your experience in clinical research and project management clearly and confidently.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re here to support you every step of the way in landing that role!
We think you need these skills to ace Signatory Business Partner
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Signatory Business Partner role. Highlight your experience in clinical writing and project management, as these are key for this position. We want to see how your skills align with what Novartis is looking for!
Showcase Your Expertise:When detailing your previous roles, focus on your experience with clinical documents and regulatory compliance. Use specific examples that demonstrate your ability to manage complex submissions and lead writing teams. This will help us understand your fit for the role.
Be Clear and Concise:Keep your application straightforward and to the point. Use clear language and avoid jargon unless it's relevant to the role. We appreciate a well-structured application that makes it easy for us to see your qualifications at a glance.
Apply Through Our Website:Don’t forget to submit your application through our website! This ensures that your application gets to the right place and helps us keep track of all candidates. Plus, it’s the best way to stay updated on your application status.
How to prepare for a job interview at WillHire
✨Know Your Documents Inside Out
Make sure you’re familiar with the types of clinical and safety documents mentioned in the job description. Brush up on Clinical Study Reports, Risk Management Plans, and CTD submission documents. Being able to discuss these confidently will show that you understand the role and its requirements.
✨Showcase Your Project Management Skills
Prepare examples from your past experiences where you successfully managed projects or collaborated across teams. Highlight how you ensured compliance with internal standards and external guidelines. This will demonstrate your ability to handle the responsibilities of the Signatory Business Partner role.
✨Understand Regulatory Compliance
Familiarise yourself with the regulatory guidelines relevant to clinical research and safety documentation. Be ready to discuss how you’ve navigated compliance issues in the past. This knowledge will be crucial in showing that you can meet Novartis's high standards.
✨Prepare for Scenario-Based Questions
Expect questions about handling technical complaints or adverse events. Think of specific scenarios where you had to respond quickly and effectively. This will help you illustrate your problem-solving skills and your commitment to patient safety.
