3 August, 2022
Novartis Hiring 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 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.
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
As per I saw your post regarding vanancy for post of job I am sending my resume for recruitment in your organisation as Novartis
Also I completed 3 months Certificate course in pharmacovigilance from Global pharma Academy pune, where i learn following skills and knowledge:
Introduction to Drug Safety and Pharmacovigilance
Key concepts and terms of Pharmacovigilance
International Regulatory requirements of Pharmacovigilance
Regional Regulatory Requirement
Aggregate reporting, Causality Assessment
Signal Detection and Risk Management Plan
Special case scenarios in Pharmacovigilance
Kindly requested to share your personal contact details for further conversation.