Expert Regulatory Writer

Salary Range:

Job Description Summary

Job Description

Key Responsibilities

• Lead the authoring of high-complexity regulatory documents, ensuring quality, accuracy, consistency and compliance.
• Provide expert regulatory writing guidance to clinical trial and submission teams.
• Partner with cross-functional teams to develop clear, scientifically robust regulatory content.
• Shape data analysis planning and the effective presentation of scientific information in regulatory documents.
• Lead regulatory writing plans and timelines, coordinating contributors to achieve critical submission milestones.
• Act as Program Writer for complex programmes, overseeing writing strategy, coordination, planning and resourcing.
• Champion best practices, new technologies and artificial intelligence tools to enhance regulatory writing quality and efficiency.

Essential Requirements

• Degree in science, healthcare, regulatory affairs, or an equivalent combination of education and relevant pharmaceutical industry experience.
• Strong medical writing or relevant pharmaceutical industry experience, combined with scientific and regulatory knowledge.
• Expert knowledge of medical writing processes and the global regulatory environment.
• Advanced understanding of biostatistics principles and their application to regulatory documentation.
• Demonstrated cross-functional leadership, with strong collaboration, communication and organisational skills.
• Ability to solve complex problems proactively and adopt new technologies, including artificial intelligence tools.

Benefits & Rewards

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: 67,900 to 126,100

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

You may be eligible for a company vehicle or a car allowance in accordance with the applicable local Novartis policies and guidelines.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering:

https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired