具体职责:

We are looking for experienced candidates for the position of RWE Specialist / Manager.


1.Support study conceptualization & design, protocol development, study conduct and publication in Medical Affairs Division (MAD), especially for following types of studies:

Studies using secondary RWD sources

Studies involving endpoints such as Patient-reported Outcomes (PROs), health economics

2.Promote to embed RWE (incl. PRO, health economics) into MAD evidence generation in close collaboration with cross-functions to address pre-identified evidence needs

Integrated evidence generation planning

New study design and protocol development

3.For studies using secondary RWD sources, drive the selection and evaluation of data sources, and contribute to study design, conduct and publication

4.Map and identify RWD sources for medical research and build research collaborations to increase the availability of fit-for-purpose RWD.

5.Contribute of lead the development of local work instructions, templates or tools in evidence generation activities:

Study design process

Protocol, synopsis templates

Retrospective studies (chart reviews or secondary RWD sources) quality control standards, e.g., the process of selection and evaluation of fit-for-purpose RWD sources

6.Keep up with the evolvement of the Chinese health eco-system and up-to-date policies, especially those relevant to evidence generation to support early access, label extension, NRDL negotiation, commercial insurance listing, and Volume-based Procurement (VBP); also promote to integrate these into MAD evidence generation planning

7.Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel

8.Assist with preparation of scientific manuscripts and publications

9.Contribute to internal/external educational initiatives in relevant fields


任职资格:

1. Master’s degree in health or science related disciplines, such as epidemiology, biostatistics, data science, etc. PhD degree is preferred.

2. With 3 + years of designing and conducting RWE (incl. PRO, HE) research for pharmaceutical products in pharmaceutical/biotechnology companies, contract research organization (CRO), or academic institutes

3. Strong oral and written communication and presentation skills in Chinese and English; Other language skills are a plus

4. Good understanding of Medical Affairs, Drug Development, Market Access/ HEOR or related disciplines to generate value evidence using various types of studies (prospective and retrospective) and data sources

Experience in planning, designing, analysis, and publication of real-world data, from both prospective and retrospective studies, with a proven success record in the field

Experience in planning, designing, analysis, and publication of HEOR studies, with a proven success record in the field

Familiar with Chinese RWD sources for medical research and aware of strengthens & limitations of these sources

Familiar with research methodologies of studies using secondary RWD sources, e.g., EMR/EHR, medical claims

Ability to interpret study data and generate sound recommendations to support data dissemination efforts

Good understanding of the evolvement of the Chinese healthcare system and up-to-date policies, e.g., Hainan Boao, Great Bay Area

Ability to effectively present information and respond to questions to various audience, e.g., project teams, review committees, KEEs, research sites, and third-party vendors

High attention to detail and the ability to work individually, within a multi-disciplinary team, and with external partners and vendors

Ability to prioritize multiple projects and deliverables, along with effective time management skills

Good understanding of clinical medical concepts and terminology

5. Proficiency in Microsoft® Office software; Familiar with scientific computing/programming software and applications, such as SAS or R