Executive/Senior Executive -Product Information Specialist
Executive/Senior Executive -Product Information Specialist
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Job Description
About your role
We have vacancy for Product information expert role in Regulatory Affairs team. We are looking for Executive/Senior executive. 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 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 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
Bachelors/Masters degree in life sciences or health-related field from a reputed college
How to apply and additional information
Email your CV on& please share below details
-Required documents CV/Resume
- Current CTC Expected CTC & Notice Period.
-Application deadline - 15.06.2025
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.
Required Experience:
Senior IC
Employment Type
Full-Time
