Description
About your role
We have vacancy for Product information expert role in Regulatory Affairs team. We are looking for Specialist- Product information Specialist. The candidate has the possibility to utilize his/her own strengths with the support of the specialists.
Your key responsibilities
Management and coordination of good quality PI documents such as company core data sheets (CCDS),
Summary of Product Characteristics (SmPCs), package leaflets (PLs) and labelling in close co-operation with
Regulatory Affairs and Pharmacovigilance, including
• Writing PI documents with support from Medical Affairs, Commercial Operations and Global Operations
• Document management and change control of PI documents
• Performing quality control of PI documents for accuracy and consistency
• Global coordination and guidance of internal PI related processes
• Assuring high quality processes, internal guidelines, standard operating procedures & internal templates

What we offer
An excellent opportunity to work as a PI-specialist in different therapeutic areas




Outstanding opportunity to become part of the wholly owned subsidiary of globally operating Orion Group
An opportunity to collaborate directly with your colleagues mainly in Finland & India, but also globally
Possibility to utilize your own strengths with the support of the professionals
Flexible, high-spirit working setting where your skills are appreciated
Hybrid Work Policy (In a week - 3 days work from office and flexibility to work remotely for two times).
Good work-life balance
Clear, transparent processes and responsible supervisors are our benefits to the personnel

At Orion, your work creates true impact and well-being for our customers, patients and society at large. ​ ​Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the devel

📌 Specialist Product Information Specialist Mumbai
🏢 Orion Pharma
📍 Mumbai