Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in haematology, immunology, neurology, and transfusion medicine.
We're looking for a Scientific Service Manager, to join our team in Turkey.
Role Purpose:
Scientific Service is the Responsible Person in charge of information on medicines which the Company puts on the market. Serves as technical and scientific reference, providing accurate, timely, fair-balanced medical information internally within Company and to external customers.
He/She is responsible for fulfilling requirements for the Scientific Service role, according to the EU Directive 2001/83/EC in general and the local laws.
Main Responsibilities:
- Compiling and collating all information received from any source concerning the medicines that the Company puts on the market.
- Ensuring that product advertisements correspond to the content of the current effective marketing authorization/registration and comply with Turkey legal requirements for advertising and promotion, as well as Company procedures and policies.
- Ensuring that regulations on advertising & promotion, external communication and interaction with healthcare professionals by the Company sales representatives are promptly implemented.
- Manages unsolicited requests for medical information from external customers (including product requests for unlicensed products in Turkey), in alignment with international best practices and Company policies and procedures.
- Reviews and approves evidence-based, balanced Medical Response Documents (MRDs) such as Standard Response Letters (SLRs) and Frequently Asked Questions (FAQs) dedicated to Turkey, ensuring compliance with local regulations.
- Reviews and approves Summary of Products Characteristics (SmPC) for products commercialized in the Country.
- Ensures records of medical inquiries, advertising & promotion review/approval process, sales representatives training, in compliance with applicable regulations, Company policies and procedures.
- Maintains global interactions, mainly with Italy, relating to compliance with regulations for advertising & promotion, therapeutic and medical information, and reporting activities.
- Responsible for setting up local procedures for the management of medical and scientific activities (Medical Inquiries Management, Promotional Material review, Scientific Training Management, etc.).
- Responsible for providing information and assistance to Regulatory Authorities, and for ensuring the decisions taken by the authorities or bodies responsible for monitoring advertising of medicinal products are immediately and fully complied with.
Requirements:
- Professional experience in related fields of at least two years.
- Professional experience in quality management in pharmaceutical industry.
- Written and spoken fluency in Turkish and English.
- Education: university studies degree in the field of pharmacy
- Place of residence: Turkey