MINS (Medical Information /Nominated Signatory) Specialist (Fixed Term)

[Job Description]

-Medical Information

• Collect, extract, evaluate, summarize and disseminate up-to-date, accurate, high-quality information with balanced and effective manner to both external and internal customers in compliant way in terms of AZ policy and regulations with the purpose of appropriate use of company products.
• Respond to company product-related questions from external customers only reactively, and make sure that patients must not be given medical advice, but instead be referred to their Health Care Providers.
• Respond to queries concerning Unauthorized Company Products or Uses in compliant way. Even though queries from Health Care Providers were indirectly received via AstraZeneca colleagues (ex. Sales reps, or MKT), response must be delivered to Health Care Providers directly, and must ensure that commercial personnel (sales reps or MKT) never be involved in communication route.
• Ensure response to queries from Health Care Providers meet all of the following requirement utilising standard responses and documentation:
• Information must only be provided in response to unsolicited queries;
• Information must be accompanied by the approved labelling, as applicable;
• All responses must be limited to the scope of the queries and must provide data which are appropriate to the source of the queries; and
• All responses must contain (as relevant) a statement that the information requested involves an Unauthorized Company Product or Use and that the Company does not recommend Unauthorized Uses of the Company Product.
• Maintains up to date knowledge of AZ therapeutic areas and products plus competitor products
• Maintains up to date knowledge of library facilities, information retrieval systems and information technology
• Maintains up to date knowledge of medical literature to evaluate and utilise appropriately in Medical Information responses
• Maintains Medical Information database for own products
• Maintains up to date knowledge of copyright and data protection regulations and operates in compliance with these requirements
• Ensure minimal personal information to be gathered for the purpose of query handling based on personal information protection law.
• Develop and maintain high-quality product knowledge enhancement tools and effectively deliver to related functions.
• Produces management reports to track volume and pattern of HCP requests, and performance against Medical Information KPIs
• Ensures timely reporting of suspected adverse events with AZ products (in conjunction with Patient Safety) in compliance with local regulatory requirements and global AZ Safety Reporting requirements
• Conduct training to AZ employees for enhancing product/disease knowledge

-Nominated Signatory

• Review promotional and specified non-promotional materials against pre-defined, principles-based criteria for approval.
• Approve local Brand Plans and Campaign Plans together with supporting promotional and non-promotional materials against pre-defined, principles-based criteria.
• Review and approve final sales representative training relating to their interactions with HCPs against pre-defined, principles-based criteria.
• Review and approve all documentation related to market research and other pre-licence activities to ensure that they are non-promotional.
• Review and pre-approve educational items for HCPs against AZ policies and standards before the item is given.
• Accountable for development of local SOPs for materials approval, re-approval, recall and document retention in line with AZ policies and local requirements.
• Accountable for ensuring that promotional materials and activities initiated by AZ global teams that involve local (home country) HCPs are in line with local codes and regulatory requirements.
• Accountable for ensuring feedback and coaching is given to originators regarding any inappropriate material and/or meeting content to prevent re-occurrence. Incorporate learning and best practice into training and revision of local procedures.
• May participate in the investigation and/or defence of complaints raised against local AZ materials/activities.
• Participate in dialogue with other companies regarding competitor materials.
• Coordinate preparation for and response to any audits related to promotional compliance.
• Conduct training to AZ employees for improving knowledge of guidance or procedures related with Nom. Sig review & approval process.

[Typical Accountabilities]

Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.

[Skills]

• Bachelors degree in pharmacy, pharmacology
• Demonstrated experience in drug information communication
• Excellent verbal and written communication skills (including English)
• Good computer and database skills
• Good knowledge of AZ therapeutic areas
• Good knowledge of AZ products
• Knowledge of regulatory environment

[Qualifications]

-Education: Relevant degree(Pharmacy)

-Language: Korean, English

-Certifications: Pharmacist License

-Work Experience: Preferred 2+ years of Pharma experience

-Competencies: Understanding of scientific data, Excellent communication skills, Problem-solving abilities

1. 전자우편으로제출한서류는채용절차법에따라, 일체반환의무가없습니다.

2. 보훈대상자 및 취업보호대상자는관련법에의거하여우대합니다.

3. 해외여행결격사유가없어야합니다.

4. 본 채용은수시진행으로, 우수인력채용 시 마감될 수 있습니다.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.