We're looking for a highly motivated and skilled Product Information Expert (Executive/Senior Executive level) to join our Regulatory Affairs team in Hyderabad. This is a unique opportunity to leverage your strengths and collaborate with a supportive team of professionals within a globally operating organization. You'll play a crucial role in ensuring the quality and consistency of vital product information documents for our diverse therapeutic areas.
Your Key Responsibilities
- Management and coordination of high-quality PI (Product Information) documents, including:
- Company Core Data Sheets (CCDS).
- Summary of Product Characteristics (SmPCs).
- Package Leaflets (PLs).
- Labelling.
- Work in close cooperation with Regulatory Affairs and Pharmacovigilance.
- 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 (SOPs) & internal templates.
What We Offer
- An excellent opportunity to work as a PI-specialist in different therapeutic areas.
- A great opportunity to become part of the wholly owned subsidiary of the globally operating Orion Group.
- An opportunity to collaborate directly with colleagues mainly in Finland & India, but also globally.
- Flexible, high-spirit working environment where your skills are appreciated.
- Hybrid Work Policy: 3 days work from the office and flexibility to work remotely for two days a week.
- Good work-life balance.
- Clear, transparent processes, and responsible supervisors.
- 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.
Our Expectations
- 4 - 7 years of experience as a Product Information Specialist in the 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 skills (MS Word, Adobe Acrobat).
- Good communication and interpersonal skills.
- Ability to prioritize, 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 a health-related field from a reputed college.
