Senior Associate Regulatory Writer

Job Description

Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis in its mission to bring innovative medicines to patients worldwide. You will collaborate with colleagues from Statistics, Data Management and Clinical Development and have the opportunity to analyze data and derive key messaging to secure approvals from Health Authorities. Read on for details about the role and how you can join a world-class organization at the forefront of the industry to advance your career.

Your responsibilities include, but are not limited to:

• To write and/or edit high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registry documents. Can contribute to Risk Management Plans (RMP).

• Coordinate outsourced activities in RWS. Participate in Clinical Trial Team (CTT).Contribute to development of processes within RWS.

• Participate in planning of data analyses and presentation used in CSRs. Documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.

• Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.

• Support the development of RWS through participating in RWS workstreams and other related activities. Maintain audit, SOP and training compliance.

Diversity & Inclusion / EEO

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

Minimum Requirements

≥ 1-year medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.

• Knowledge of global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).

• Excellent communication skills (written, verbal, presentations). Operational knowledge of clinical trial reporting. Knowledge of biostatistics principles.

• Ability to prioritize and manage multiple demands and projects. Ability to define and solve complex problems (“Problem-solver”).

• Broad knowledge and future oriented perspective. Proven track record in matrix environment.

• Experience in contributing to global, cross-functional projects. Global, cross-cultural perspective and customer orientation.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here.
https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:
https://www.novartis.com/careers/benefits-rewards

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about
Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network