Closely working with medical writers and clinical physicians to contribute to clinical study related medical writing activities to meet customer’s clinical trial project needs. He / she will carry out day-to-day hands-on work and maintain good medical writing relationships with project related stakeholders internally and externally.
- To work directly with medical writing manager, clinical physician, biostatistician, programmers, or relevant parties involved in all medical writing activities.
- To carry out hands-on medical writing in accordance with company SOPs and GCP.
- To participate in the discussion and drafting the clinical development plan and editing
- To prioritize and plan workload to a high standard
- To work directly with medical team and clinical research physician to carry out clinical study related medical writing including IB, study synopsis, protocol, CSR, clinical document translation.
- To search product, target indication with market analysis and report
- To be involved in the preparations on the documentation for regulatory submissions (e.g. investigator brochures, protocols, and CSR).
- Develop and maintain solid knowledge of the relevant therapeutic areas and medical writing techniques.
- To undertake any activities involving writing and communication with others, internally and externally, as requested.
Professional Experience & Education Requirement
- Bachelor degree in Medicine, pharmacology or other life science degrees (or equivalent).
- For Specialist, 2+ years of experience in medical writing or clinical science or relevant experience in biopharmaceutical or CRO companies.
- For Senior Specialist, 4* years of experience in medical writing, clinical science or relevant experience, plus complex and large scale project management experience in biopharmaceutical or CRO companies.
Key Competency Requirement
- Understand clinical trial operation process.
- Have good knowledge of the regulatory guidance for ICH/GCP.
- Excellent Chinese and English written and verbal communication skills; Excellent scientific and technical writing skills in both Chinese and English.
- Ability to write fluent and grammatically correct English with solid understanding of medical and scientific terminology and procedures.
- Ability to work to tight timelines and changing needs while maintaining accuracy and quality.
- Ability to work to a variety of client-driven specifications.
备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。