We have vacancy for Product information specialist role in Regulatory Affairs team. Management and coordination of good quality Product information 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
Assuring high quality processes, internal guidelines, standard operating procedures & internal templates
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).
Positive work-life balance
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 .
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
Ability to prioritise, manage multiple projects & meet deadlines while delivering high quality documents
Ability to work within teams (often remotely) as well as independently
Bachelor's/Master's degree in life sciences, B.Pharm/M.Pharm or health-related field from a reputed college
Orion is a globally operating Finnish pharmaceutical company – a builder of well-being for over a hundred years.
We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. The core therapy areas of our pharmaceutical R&D; are oncology and pain. Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.
At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. 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.