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- Tasks: Craft impactful clinical documents and lead writing teams for regulatory submissions.
- Company: Join Novartis, a leader in the pharmaceutical industry with a commitment to diversity.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real difference in global health by ensuring regulatory success.
- Qualifications: Life science degree, fluent in English, and strong medical writing experience.
- Other info: Dynamic role with a focus on mentorship and collaboration in a fast-paced environment.
The predicted salary is between 36000 - 60000 £ per year.
Job Description Summary
#LI-Hybrid (12 days per month on-site) Location: London (The Westworks), United Kingdom
Are you passionate about crafting clear, impactful clinical and safety documentation that drives regulatory success? 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.
Job Description
Major accountabilities
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Author, review, and/or independently manage high-quality clinical and safety documents, including: Complex Clinical Study Reports (CSRs), Protocols, Concept Sheets, and Informed Consent Forms (ICFs), Complex CTD submission documents (e.g., Clinical Overviews, Summaries of Clinical Efficacy and Safety, Clinical Pharmacology and Biopharmaceutics), Other regulatory documents (e.g., Briefing Books, responses to Health Authority questions).
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Lead writing teams for complex submissions, contribute to key messaging and pooling strategy, and provide expert guidance on clinical content within the CTD.
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Ensure documentation complies with internal standards and external regulatory guidelines.
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Input into planning and presentation of data analyses, including reviewing statistical analysis plans and participating in relevant meetings.
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Act as documentation expert within Global Clinical Teams (GCTs) and Clinical Submission Teams (CSTs).
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Provide strategic and content expertise for clinical sections of the CTD.
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Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.
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Distribute marketing samples, where applicable.
Essential Requirements
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University life science degree or equivalent.
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Fluent in English (oral and written).
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Proficient in medical writing or other relevant pharmaceutical industry roles, with strong scientific and regulatory knowledge and deep understanding of medical writing processes.
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Expert knowledge of global regulatory environments and processes, including key regulatory bodies, core submission documents, approval pathways, and safety reporting requirements.
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Proven expertise and successful track record in global drug registration.
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Exceptional communication skills – written, verbal, and presentation.
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Strong understanding of biostatistics principles and their application in regulatory documentation.
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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’s representative of the patients and communities we serve.
Skills Desired
- Clinical Research
- Clinical Trials
- Detail-Oriented
- Medical Writing
- People Management
- Regulatory Compliance
- Safety
- Waterfall Model
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Expert Regulatory Writer employer: Healthcare Businesswomen’s Association
Contact Detail:
Healthcare Businesswomen’s Association Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Expert Regulatory Writer
✨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 showcase your expertise.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression. We believe it shows your enthusiasm and professionalism, which can set you apart from other candidates.
✨Tip Number 4
Apply through our website for the best chance at landing the role. We make it easy for you to showcase your skills and experience directly to our hiring team, so don’t miss out!
We think you need these skills to ace Expert Regulatory Writer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Expert Regulatory Writer role. Highlight your experience with clinical documents and regulatory submissions, as this will show us you understand what we're looking for.
Showcase Your Skills: Don’t just list your qualifications; demonstrate how your skills align with the job description. Use specific examples from your past work that showcase your expertise in medical writing and regulatory processes.
Be Clear and Concise: We love clarity! Ensure your application is well-structured and easy to read. Avoid jargon unless it’s relevant to the role, and keep your sentences straightforward to make a strong impression.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Healthcare Businesswomen’s Association
✨Know Your Documents Inside Out
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, exceptional communication is key. Prepare to demonstrate your ability to convey complex information clearly. You might even want to bring examples of your previous work to highlight your writing style and clarity.
✨Prepare for Team Dynamics
Since this role involves leading writing teams, think about your past experiences in team settings. Be ready to share how you’ve mentored others or contributed to cross-functional projects, showcasing your leadership and collaboration skills.
✨Understand the Bigger Picture
Familiarise yourself with the global regulatory environment and the specific challenges faced by the company. This will help you articulate how you can contribute to their success and navigate the complexities of drug registration effectively.