Expert Regulatory Writer

Novartis Farmacéutica; London; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company in London is seeking a skilled Medical Writer to manage high-quality clinical and safety documentation crucial for global regulatory submissions. The ideal candidate will have a life science degree, fluency in English, and proven expertise in medical writing within the pharmaceutical industry. This role emphasizes collaboration across teams to ensure excellence in documentation and compliance with regulatory standards.

Qualifications

• Proficient in pharmaceutical industry roles with regulatory knowledge.
• Exceptional communication skills in writing and presentation.
• Demonstrated ability to manage multiple projects in fast-paced environments.

Responsibilities

• Author and manage high-quality clinical and safety documents.
• Lead writing teams for complex submissions and provide guidance.
• Ensure documentation complies with internal and regulatory standards.

Skills

Medical writing

Fluent in English

Strong communication skills

Biostatistics understanding

Education

University life science degree or equivalent

Job description

#LI-Hybrid
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.

About the Role

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? https://www.novartis.com/about/strategy/people-and-culture

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: https://talentnetwork.novartis.com/network

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.