Are you an experienced Regulatory Writer looking for an exciting opportunity with a global pharmaceutical leader? Novartis is hiring for the role of Regulatory Writer in Mumbai and Hyderabad. If you have a background in medical writing, clinical research, and regulatory compliance, this could be your next career move!
Job Description: Regulatory Writer at Novartis
Key Responsibilities:
- Author and review high-quality clinical and safety documents, including Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Risk Management Plans (RMP).
- Lead outsourced narrative projects and coordinate regulatory writing activities.
- Serve as a core member of Clinical Trial Teams (CTT) and Safety Management Teams (SMT).
- Ensure compliance of documentation with internal standards and external regulatory guidelines.
- Act as a Program Writer to maintain consistency across documents and manage medical writing resources.
- Collaborate with publishing teams for timely document submission.
- Contribute to process improvements within Regulatory Writing Services (RWS).
- Maintain audit, SOP, and training compliance.
Skills & Qualifications:
- 3-5 years of medical writing experience (or 1-3 years with MBBS/PhD).
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH guidelines).
- Experience in clinical research, drug safety, and regulatory submissions.
- Excellent communication, writing, and problem-solving skills.
- Ability to manage multiple projects in a matrix environment.
- Familiarity with biostatistics and risk management plans.
Why Join Novartis?
Novartis is a global leader in healthcare and pharmaceuticals, committed to innovation and improving patient outcomes. With a strong presence in Mumbai and Hyderabad, Novartis offers a dynamic work environment, career growth opportunities, and competitive benefits.
