노보노디스크제약(주)는 덴마크 코펜하겐을 본사로 둔 글로벌 제약사로, 한국 지사의 경우 사원수 210명 (현재 기준), 매출액 1,651억 7,834만원 (2019년 12월 기준) 규모의 외국계 제약사입니다. 송파구 잠실에 위치하고 있으며, 당뇨 관리 제품, 비만치료, 혈우병 관리 제품, 성장 호르몬 치료사업을 하고 있습니다.

 https://www.novonordisk.co.kr/

 <Job Description>

 Contract Period

The contract period is 1 year, and this position can be possibly extended in its contract after 1 year. 

 Position’s key accountabilities

​Support execution and implementation of non-interventional studies and other Real-World Evidence generating studies to support the NNPK evidence generation plan with partners and with vendors.

Contribute to driving innovation in RWE analytics by implementing new analytic methods, study design and technologies to answer research and business questions.

Support conducting RWE studies using internal and external real world data to generate unique disease insights and epidemiological information to improve patient care and support business needs.

Communicate RWE matters with key internal stakeholders and scientific community.

 

Nature and scope of Main accountabilities

Collaborate with external vendors RWE projects and manage communication, contracting and project follow up with external vendors (ex. CROs) and ensure expected deliverables and meet timelines / challenges content for low or medium complexity projects.

Identify Real World Data sources (electronic medical records, registry database, patient reported outcomes survey, and national claims database) which best support business needs through literature reviews and desk research etc.

Able to interpret, understand and discuss data results, protocol, SAP, NSR and other study related materials, and collaborate with internal stakeholders and external vendors with timely and efficient communications.

Collaboration in study operations with RWE manager:

          - Provide input for feasibility and operation perspectives to study outline,

          - Prepare study protocol, informed consent and amendments, if applicable,

          - Provide input to study and project related documents (e.g. CRF, NSR, Study Validation Plan),

          - Ensure availability of other study related documents, e.g monitoring guidelines,

          - Plan and conduct investigator meetings and other meetings incl. Investigator Result meeting(s),

          - Ensure audit and inspection readiness,

          - Handling protocol deviations (if applicable) to ensure high compliance,

          - Ensure compliance with all existing applicable requirements, and overall ensuring compliance with GCP and other applicable external regulations for the non-interventional studies as well as Criteria for medical drug promotion and local regulations in the local meetings within and outside the study community.

 

Background knowledge of industry trends and best practices specifically related to epidemiology/outcomes research.

Good knowledge and understanding of applicable regulations in pharmacoepidemiology, pharmacovigilance and clinical development.

Conduct literature reviews andline research to support Real World Evidence projects.

Combination of strong methodological quantitative knowledge, strategic, innovative thinking, and communication skills.

Prepare presentation materials (in PowerPoint) and assist in document development (in Word & Excel) for Real World Evidence protocols, reports, manuscripts, posters, etc.

<지원자격>

Degree in statistics, public health, or other health related fields.

·Master’s degree in a field such as epidemiology, biostatistics, statistics, bioinformatics, economics or similar is preferred.

Minimum of two to three years of related experience conducting research in the pharmaceutical industry, contract research organization, healthcare provider / HTA or academic institute; or experience in a closely related discipline within the pharmaceutical industry.

 The ability to develop understanding of retrospective and prospective research methods, late phase study designs, HEOR and related methodology.

 Record of publications in observational research is a plus.

 Experience working with longitudinal RWD (e.g., claims, electronic health records, and/or surveys).

 Experience in the conduct of non-interventional study, late phase study, or database study.

 Experience in using statistical software (e.g., R, SAS, Python, SPSS, and/or Stata).

 Collaborative approach to problem-solving and ability to plan and multi-task.

 Excellent written and oral communication skills.

 Excellent communication, presentation, interpersonal skills, both written and spoken.

 Proficiency in Excel, Word and PowerPoint.

 Fluency in written and spoken English.

<고용형태> 계약직

<전형방법> 1차 서류전형 - 2차 면접전형

<접수방법> 홈페이지 접수 https://careers.novonordisk.com/job/Seoul-Real-World-Evidence-Associate-Seou/794804401/

<문의사항> ylkm@novonordisk.com /  imkz@novonordisk.com