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.

Essential Requirements:

• 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 team’s representative of the patients and communities we serve.