Global Clinical Publishing Associate

200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide.
- Your Responsibilities:

- Your responsibilities include but not are limited to:
- Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
- Ensures compliance to the requirements from regulatory agencies.
- Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products
- Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records.
- Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.
- May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.
- May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.
- May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**
- What You’ll bring to the role:
- At least 2 year of relevant experience in Regulatory domain with an exposure of working in global organization is preferred. Fresh campus graduates with high learning agility can be considered.
- Organizational awareness and experience working cross-functionally and in global teams is a plus
- Ability to work under pressure, demonstrating initiative and flexibility
- High level understanding of Regulatory quality, standards and policies.
- Attention to detail and quality focused
- Team-minded

Why consider Novartis?
- 769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
- We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
- Imagine what you could do at Novartis
- Commitment to Diversity & Inclusion:

- Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
- Join our Novartis Network:

- If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
**Division**
- Global Drug Development

**Business Unit**
- REG AFFAIRS GDD

**Country**
- India

**Work Location**
- Hyderabad, AP

**Company/Legal Entity**
- Nov Hltcr Shared Services Ind

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No