Expert Regulatory Writer

Location: London (The Westworks), United Kingdom (12 days per month on-site)

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 supporting 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, 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).
• 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.

Qualifications:

• University 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 teams that are 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. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.