Title: Medical Information and Document Management，Senior Manager
Department: China Clinical Development
Reports to: Head of Clinical Operation and Innovation
Date: 1 May 2019
Summary:This role leads Medical Writing and Translation activities, both internal and external, including researching, writing, translating and editing of clinical study reports, protocols, Investigator’s Brochures, and IND/CTA, NDA/BLA or other regulatory submission
Lead and direct medical writing and translation activities from IND/CTA to NDA/BLA for the clinical trials/programs, as well as publication activities for the purpose of new product launch; ensure appropriate resources are in place to support all medical writing and translation needs to deliver documents for regulatory submissions and publications within established timelines and budget.
Contribute to overall project management and to cross-functional working groups (regulatory affairs, clinical operations, clinical development, data management, and statistics) as needed to facilitate efficient development and finalization of clinical, non-clinical and regulatory documents for submissions.
Ensure that medical writing and translation activities are coordinated with other functions, including Clinical Operations, Pharmacovigilance, Regulatory and other groups.
Establish and maintain the operational standards for the medical writing and translation activities (e.g. style guidelines, templates, QC and etc.).
Manage the completion of documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
Manage the work of CRO for medical writing and translation.
Evaluate supplier capability and identify qualified supply sources based on procurement policy and process.
Be responsible for the relationships with suppliers to ensure information protection, drive performance management, deliver continuous quality and cost improvement.
Process the medical writing and translation requests to CROs and/or other relevant suppliers: preparing, dispatching, managing, and communicating the requests, and coordination with external suppliers worldwide.
Conduct the review of supplier performance and address issues of non-conformance or low performance.
Ensure negotiations are being conducted to the best value and total cost of ownership and according to confidentiality and compliance requirements.
Participate in recruiting and mentoring of staff, and budget planning.
Perform other related duties as assigned by management.
Master in Life Science or equivalent
At least 3 years in medical writing and 3 years in translation, including participating in IND/CTA and/or NDA/BLA submissions to the China NMPA (SFDA), US FDA, or EMA (MAA)
Experiences in preparing documents in English and Chinese, including protocols, study reports, investigator brochures, safety updates, and clinical sections in regulatory dossiers, as well as publications
Attention to detail with an ability to perform critical review of various types of documents
Demonstrated ability to communicate and write clearly, concisely, and effectively, with an aptitude for compilation, analysis, and presentation of data
Strong understanding of process implications as related to strategic sourcing, cost reduction, and quality management
Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to demanding timelines
Knowledge of drug development, clinical research, study design, biostatistics, regulatory environment, and medical terminology
Ability to think strategically to drive the project and departmental development further
Demonstrated ability to work as a team player with multi-disciplinary project teams
Independently motivated, good problem-solving ability, and work cross-culturally
Excellent oral and written communication skills in Chinese and English
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.