Medical Translation-KunTuo
On-siteShanghai, Shanghai, China
Job Summary
Lead advanced medical writing projects including complex clinical study reports, protocols, and challenging indications. Confirm task scope, templates, and specifications while negotiating timelines and resolving customer comments. Manage day-to-day workload by tracking progress, identifying risks, and communicating directly with customers and senior staff. Lead customer meetings independently, deliver training on writing processes, and act as Project Manager for short-term initiatives. Monitor and forecast project budgets, propose SOP revisions, and integrate data from diverse sources. Maintain current knowledge of Good Clinical Practice and regulatory developments.
Required Qualifications
- Bachelor's Degree in life sciences related discipline or related field
- Master's Degree in life sciences related discipline or related field
- Ph.D. in life sciences related discipline or related field
- At least 3 years of prior relevant experience and related competency levels
- Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents
- Ability to identify deficiencies, errors, and inconsistencies in a protocol or report
- Good understanding of common statistical methods used in clinical trials and/or interpretation of their results
- Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
- Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues
- In depth knowledge of drug development, medical writing, and associated regulations
- Good understanding of statistical principles and of medical terminology across a range of therapeutic areas
- Excellent written and oral communication skills including grammatical/technical writing skills
- Excellent attention to detail and accuracy
- Communicates clearly, effectively and confidently with others
- Demonstrated abilities in collaboration with others and independent thought
- Demonstrates confidence and maturity in most routine medical writing situations
- Demonstrates good judgement in requesting input from senior staff
- Ability to establish and maintain effective working relationships with coworkers, managers and customers
- Ability to effectively manage multiple tasks and projects
- Ability to proactively identify potential issues/risks, consider solutions, and raise with the customer, with senior guidance and input
- Must be computer literate
Desired Qualifications
- Bachelor's Degree in life sciences related discipline or related field
- Master's Degree in life sciences related discipline or related field
- Ph.D. in life sciences related discipline or related field
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