At a Glance
- Tasks: Create and manage high-quality clinical documents that impact patient lives.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Hybrid work model, competitive pay, and the chance to make a real difference.
- Other info: Opportunity for growth in a supportive and collaborative environment.
- Why this job: Be part of a passionate team dedicated to transforming healthcare and improving lives.
- Qualifications: Experience in medical writing and strong attention to detail required.
The predicted salary is between 40000 - 50000 £ per year.
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.
- 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 directsourceproteam@prounlimited.com.
Medical Writer – Clinical Regulatory Documentation employer: Novartis
At Novartis, we are dedicated to making a meaningful impact on human lives, and as a Medical Writer, you will be part of a collaborative and innovative community that values your expertise. Our hybrid work model promotes a healthy work-life balance while providing opportunities for professional growth and development in the dynamic field of clinical regulatory documentation. Join us in our mission to create breakthroughs that change patients' lives, and experience a supportive culture that encourages teamwork and excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Medical Writer – Clinical Regulatory Documentation
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Novartis.
We think you need these skills to ace Medical Writer – Clinical Regulatory Documentation
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Novartis.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Novartis. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Novartis
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Novartis.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Novartis achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
