Opportunity to work as Senior Regulatory Writer at Novartis- Apply before 20th July 2024


Website Novartis

About Novartis

Novartis is a global healthcare company based in Switzerland. It is one of the world’s largest pharmaceutical companies, focusing on the research, development, manufacturing, and marketing of healthcare products. The company’s mission is to discover new ways to improve and extend people’s lives.

Novartis operates in various segments, including pharmaceuticals, eye care, and generic medicines. It is known for producing innovative medicines in areas such as oncology, immunology, dermatology, cardiovascular, renal, and metabolic conditions. Novartis has a strong commitment to research and development, investing heavily in cutting-edge technologies and new therapeutic solutions.

In addition to its pharmaceutical products, Novartis is also involved in initiatives to improve global health, including programs to combat neglected diseases and efforts to expand access to healthcare in underserved regions.

Senior Regulatory Writer

Job Description

Summary Join a dynamic team at Regulatory Writing and Submissions (RWS) where we crafted over 10,000 individual regulatory documents in 2019 alone! Be part of a global team of nearly 200 regulatory professionals spanning 6 countries, supporting Novartis in delivering innovative medicines worldwide. Collaborate with experts from Statistics, Data Management, and Clinical Development to analyze data and shape key messages crucial for securing Health Authority approvals. Explore the role details below and seize the opportunity to advance your career with a leading industry organization.

Job Description

  • Author, review, and manage high-quality clinical and safety documents, including complex Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP), and submission documents.
  • Integral member of Clinical Trial Teams (CTT) and contributor to Safety Management Teams, ensuring documentation compliance with internal standards and regulatory guidelines.
  • Program Writer responsible for ensuring adequate medical writing resources and consistency across assigned programs.
  • Lead Writer for straightforward submissions, guiding content strategy, and ensuring document compliance.
  • Contribute to process enhancements within RWS and cross-functional initiatives, coaching and mentoring junior writers.
  • Facilitate cross-functional communication to optimize document quality and compliance with audit, SOP, and training requirements.

Candidate Profile

  • Minimum 4 years of medical writing experience or equivalent pharma industry expertise with strong scientific and regulatory knowledge.
  • Advanced understanding of global regulatory environments and processes.
  • Exceptional communication skills across written, verbal, and presentation formats, coupled with proficiency in biostatistics principles.
  • Strong prioritization abilities to manage multiple projects and complex problem-solving skills.
  • Broad industry knowledge and a forward-thinking perspective to drive organizational and team performance in diverse cultural settings.

Additional Information

  • Experience: Minimum 4 years
  • Location: Hyderabad
  • Industry Type: Pharma/ Healthcare/ Clinical Research
  • Division: Development
  • Business Unit: Innovative Medicines
  • End Date: 20th July 2024

Apply Online

To apply for this job please visit www.novartis.com.