Specialist - Product information Specialist

Posted 9 Days Ago
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Mumbai, Maharashtra, IND
Hybrid
Senior level
Pharmaceutical • Manufacturing
The Role
Manage and coordinate high-quality product information (CCDS, SmPCs, PLs, labelling). Write and control PI documents, perform quality checks, manage document change control, and guide global PI processes in collaboration with Regulatory Affairs, Pharmacovigilance, Medical Affairs and Commercial Operations.
Summary Generated by Built In

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 professionals.

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
  • Great 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 environment 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 development of innovative solutions and improving the quality of life.

Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/.

Our expectations

• 4 - 7 years of experience as Product Information Specialist in Pharmaceutical industry
• Advanced writing skills (e.g. SmPC, PL, other regulatory documents)
• Ability to understand complex medical terminologies and convert them into simple language
• Advanced computer and word processing (MS Word, Adobe Acrobat) skills 
• Good communication and interpersonal skills
• Ability to prioritise, manage multiple projects & meet deadlines while delivering high quality documents
• Ability to work within teams (often remotely) as well as independently
• Positive attitude and willingness to learn and adapt, but also to teach and support co-workers and 
colleagues around the world
• Ability to keep sight of the bigger picture, while at the same time paying attention to details.
• Ability to work in a highly regulated industry

 Qualification
Bachelor’s/Master’s degree in life sciences, B.Pharm/M.Pharm or health-related field from a reputed college

How to apply and additional information

Email your CV on [email protected] & please share below details,

-          Required documents, CV/Resume

-          Current CTC, Expected CTC & Notice Period.

-          Application deadline - 15.10.2026

 Employer Description

Orion is a globally operating Finnish pharmaceutical company – a builder of well-being for over a hundred years.
Orion provides meaningful work for more than 3 600 Orionees in Finland and abroad. Orion is known as a responsible and reliable employer where we value each other, strive for the best and build for tomorrow.
 

We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others.

About Orion

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.

We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.

About Orion

Skills Required

  • 4-7 years of experience as Product Information Specialist in Pharmaceutical industry
  • Bachelor's or Master's degree in life sciences, B.Pharm/M.Pharm or health-related field
  • Advanced writing skills for SmPC, PL and other regulatory documents
  • Ability to understand complex medical terminology and simplify language
  • Advanced computer and word processing skills (MS Word, Adobe Acrobat)
  • Document management and change control experience for PI documents
  • Experience performing quality control of PI documents for accuracy and consistency
  • Good communication and interpersonal skills
  • Ability to prioritise, manage multiple projects and meet deadlines
  • Ability to work in teams (often remotely) and independently
  • Attention to detail while maintaining view of the bigger picture
  • Ability to work in a highly regulated industry
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The Company
HQ: Dhaka
3,363 Employees

What We Do

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals as well as active pharmaceutical ingredients, combining our trusted expertise with continuous innovation. We have an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by us are used to treat cancer, respiratory diseases and neurological diseases, among others. In 2025 our net sales amounted to EUR 1,890 million and we employ about 4,000 professionals worldwide, dedicated to building well-being. Product related questions and feedback: https://www.orionpharma.com/feedback Beware of any recruitment scam using Orion Pharma’s name Be cautious of recruitment scams where individuals pose as Orion Pharma employees or authorized recruiters. Orion Pharma will never request payment, personal financial information, or any favours at any stage of our hiring process.

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