At a Glance
- Tasks: Lead the creation of high-quality regulatory documents and mentor emerging talent.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Enjoy competitive rewards, personal growth opportunities, and a supportive work culture.
- Other info: Diverse and inclusive environment with flexible working arrangements.
- Why this job: Make a real difference in patients' lives through impactful regulatory writing.
- Qualifications: Life science degree and expertise in medical writing required.
The predicted salary is between 36000 - 60000 £ per year.
Expert Regulatory Writer – Novartis (London)
We’re looking for a skilled and experienced Medical Writer to lead the development of high‑quality submissions that support global marketing applications. In this pivotal role, you’ll provide expert guidance across cross‑functional teams, mentor emerging talent, and ensure excellence in every document delivered.
Major Accountabilities
- Author, review, or independently manage high‑quality clinical and safety documents, including Complex Clinical Study Reports (CSRs), Protocols, Concept Sheets, Informed Consent Forms (ICFs), complex CTD submission documents (e.g., Clinical Overviews, Summaries of Clinical Efficacy and Safety, Clinical Pharmacology and Biopharmaceutics), and other regulatory documents (e.g., Briefing Books, responses to Health Authority questions).
- Lead writing teams for complex submissions, contribute to key messaging and pooling strategy, and provide expert guidance on clinical content within the CTD.
- Ensure documentation complies with internal standards and external regulatory guidelines.
- Input into planning and presentation of data analyses, including reviewing statistical analysis plans and participating in relevant meetings.
- Act as documentation expert within Global Clinical Teams (GCTs) and Clinical Submission Teams (CSTs).
- Provide strategic and content expertise for clinical sections of the CTD.
- Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.
- Distribute marketing samples where applicable.
Essential Requirements
- University level life science degree or equivalent.
- Fluent in English (oral and written).
- Proficient in medical writing or other relevant pharmaceutical industry roles, with strong scientific and regulatory knowledge and deep understanding of medical writing processes.
- Expert knowledge of global regulatory environments and processes, including key regulatory bodies, core submission documents, approval pathways, and safety reporting requirements.
- Proven expertise and successful track record in global drug registration.
- Exceptional communication skills – written, verbal, and presentation.
- Strong understanding of biostatistics principles and their application in regulatory documentation.
- Demonstrated ability to manage multiple priorities and projects effectively in a fast‑paced environment.
Commitment to Diversity & Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.
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 to achieve breakthroughs that change patients’ lives.
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
Location
London (The Westworks), United Kingdom – 12 days per month on‑site (12 days per month on‑site)
Expert Regulatory Writer in City of London employer: Novartis
Novartis is an exceptional employer that fosters a collaborative and inclusive work culture, where skilled professionals can thrive in their careers. With a commitment to employee growth and development, Novartis offers unique opportunities to lead impactful projects in the heart of London, while enjoying a flexible work arrangement that promotes work-life balance. Join us to be part of a passionate community dedicated to making a difference in patients' lives through innovative science and teamwork.
StudySmarter Expert Advice🤫
We think this is how you could land Expert Regulatory Writer in City of London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory writing field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulatory environments and processes. We recommend practising common interview questions related to medical writing and being ready to discuss your past experiences in detail.
✨Tip Number 3
Showcase your expertise! Bring along samples of your previous work to interviews, especially those that highlight your ability to manage complex submissions. This will demonstrate your skills and give you an edge over other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Expert Regulatory Writer in City of London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Expert Regulatory Writer role. Highlight your experience in medical writing and any relevant regulatory knowledge. We want to see how your skills align with what Novartis is looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you the perfect fit. Don’t forget to mention your understanding of global regulatory environments!
Showcase Your Communication Skills:Since exceptional communication is key for this position, make sure your application reflects that. Use clear, concise language and ensure there are no typos or grammatical errors. We want to see your writing prowess right from the start!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It’s the best way for us to receive your application and keep track of it. Plus, you’ll find all the details you need about the role there!
How to prepare for a job interview at Novartis
✨Know Your Documents Inside Out
Before the interview, make sure you’re familiar with the types of documents you'll be working on, like Clinical Study Reports and Informed Consent Forms. Brush up on the latest regulatory guidelines and be ready to discuss how your experience aligns with these requirements.
✨Showcase Your Communication Skills
As an Expert Regulatory Writer, communication is key. Prepare examples that highlight your ability to convey complex information clearly. Think about times when you’ve had to present data or mentor others, and be ready to share those stories.
✨Demonstrate Your Regulatory Knowledge
Familiarise yourself with global regulatory environments and processes. Be prepared to discuss specific regulatory bodies and submission pathways. This will show that you not only understand the writing aspect but also the broader context in which it operates.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in previous roles, especially regarding compliance and documentation. Practising your responses can help you articulate your thought process effectively during the interview.
