At a Glance
- Tasks: Create and manage high-quality clinical documents that impact global health.
- Company: Join Novartis, a leader in healthcare making a difference worldwide.
- Benefits: Gain valuable experience in a hybrid role with flexible working arrangements.
- Other info: Opportunity for growth in a dynamic and supportive environment.
- Why this job: Make a real impact on human lives through your writing and expertise.
- Qualifications: Experience in medical writing and project management is essential.
The predicted salary is between 40000 - 50000 £ 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, other documents for health authorities.
- 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.
Work details
- Workload: 35 hours/week.
- Type: Hybrid (3 days/week onsite).
- Required start date: June 2026.
- Contract: until 25 December 2026.
- Inside IR35: Yes.
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.
Medical Writer – Clinical Regulatory Documentation in London employer: WillHire
At Novartis, we are committed to making a meaningful impact on human life, and as a Medical Writer, you will play a crucial role in this mission. Our hybrid work culture promotes flexibility and collaboration, allowing you to thrive while contributing to high-quality clinical documentation. With opportunities for professional growth and a focus on regulatory compliance, Novartis is an excellent employer for those looking to advance their careers in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Medical Writer – Clinical Regulatory Documentation in London
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We think you need these skills to ace Medical Writer – Clinical Regulatory Documentation in London
Some tips for your application 🫡
Highlight Your Relevant Experience:In the human medicine field, it's crucial to showcase any relevant clinical or research experience you have. Even for temporary roles, mention internships, volunteer work, or any shadowing you’ve done with healthcare professionals to demonstrate your passion and familiarity with the field.
Certifications Count!:Don't forget to include any medical certifications or training you've completed, even if they’re temporary. These could be things like CPR or first aid certifications, which are often essential in human medicine roles and can set you apart from other applicants.
Show Your Eagerness to Learn:Since this is a temporary role, your motivation to learn and adapt is key! Use your cover letter to express your excitement about gaining real-world experience and how this role aligns with your career aspirations in human medicine. Let them know you're keen to absorb every bit of knowledge!
Tailor Your CV for Each Application:Make sure to customise your CV for WillHire by highlighting experience and skills that match the job description. Use relevant keywords and phrases specific to human medicine, so your application really stands out and shows you’re genuinely interested in this temporary opportunity.
How to prepare for a job interview at WillHire
✨Show Off Your Skills in Action
In the human medicine field, practical skills are a must. If your temporary role involves patient interaction or technical procedures, be ready to discuss specific examples where you've put your skills to use. They might even throw in a scenario-based question to see how you handle real-life situations, so think through your experiences!
✨Stay On Top of Current Practices
Human medicine is always evolving, so brush up on the latest treatment protocols and technologies relevant to your field. Mentioning recent innovations or case studies during your interview with WillHire not only shows your passion but also your commitment to staying informed in a fast-paced environment.
✨Be Ready to Discuss Flexibility
Since this is a temporary position, your ability to adapt is key. Prepare a few anecdotes about times you've quickly changed your approach or filled in for a colleague. WillHire will want to know that you can seamlessly step into various roles as needed.
✨Highlight Your Learning Mindset
Temporary roles in human medicine often lead to valuable learning experiences. Emphasise your eagerness to learn and grow in this position. Be ready to express how quickly you can pick up new skills, and how you're looking to make the most of your time in the role at WillHire.
