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Consulting-Data & AI Strategy Consultant - Life Science R&D
Shanghai
Job No. r00230764
Full-time
Job Description
Overview
- Serves as a bridge between scientific research and clinical practice. This role requires a deep understanding of both medical science and the research and development (R&D) process.
- Works closely with scientists, clinicians, and regulatory affairs professionals to ensure that research projects align with clinical needs and regulatory requirements
Responsibilities:
- Medical Expertise:
o Provide medical expertise and guidance to R&D projects.
o Stay up-to-date with the latest medical literature and research findings, particular in respiratory, oncology therapeutic areas.
o Evaluate the clinical relevance and potential impact of research projects.
- Regulatory Compliance:
o Ensure that research projects comply with relevant regulations and guidelines (e.g., primarily CFDA; FDA, EMA, ICH where relevant).
o Advise on regulatory strategies and submission requirements.
o Collaborate with regulatory affairs professionals to prepare and submit regulatory documents.
- Clinical Research Design:
o Advise on application of digital and data technologies in the design and execution of clinical trials.
o Leverage client’s input on study protocols, patient selection criteria, and data collection methods, to apply to data/ AI/ digital projects.
o Advise on digital methods to improve transparency of progress of clinical trials and uplift data quality.
- Scientific Communication:
o Communicate benefits of digital and data technologies to drive research findings to internal and external stakeholders, including scientists, clinicians, and regulatory bodies.
- Collaboration:
o Work closely with client experts (i.e., scientists, clinicians, and regulatory affairs professionals) to ensure effective collaboration and successful project delivery.
o Build strong relationships with client R&D stakeholders and external partners, such as academic institutions and healthcare providers.
- Medical Writing:
o Familiarity with medical writing requirements, such as clinical study reports, protocols, and regulatory submissions.
o Ensure that medical writing is clear, concise, and accurate
Qualifications
Qualifications:
- MD or PhD degree in a relevant medical field.
- 5+ years of experience in medical research or clinical practice.
- 3+ years of experience in a consultancy role.
- Strong understanding of the drug development process and regulatory requirements.
- Excellent Mandarin Chinese and English communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong medical writing skills. - Knowledge of relevant regulatory guidelines and standards
