1.A PhD, PharmD or MD equivalent degree in Clinical Pharmacology, Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline with significant modeling-related content and 10+ years relevant work experience in clin ical drug development;
2.Excellent knowledge of phase I-3 clinical design, operation, drug development, global study regulatory requirements and PK/PD analysis and industry experience in applications of basic research and translational medicine in clinical design and execution;
3.Excellent experience with quantitative approaches, modeling and simulation in drug development, and working knowledge of relevant modeling software such as NONMEM, WinNonlin, R, SimCYP, and GastroPlus is desired;
4.Knowledge of the latest developments in clinical pharmacology, proof-of-concept investigation and guidance documents and evidence of hands-on experience in the application of pharmacometrics methods to drug development;
5.Strong ability to perform PK/PD data analyses, interpret clinical data and their relation to the clinical setting and able to handle multiple clinical pharmacology programs simultaneously;
6.Drug development experience in one or more therapeutic areas with working knowledge of clinical and regulatory landscape, patient populations, disease mechanisms, treatment paradigms, and competitive landscapes;
7.Strong track record of publications and able to apply scientific knowledge to the company's products, identify issues, apply insightful analysis, and solve problems effectively;
8.Strong consulting skills in the drug development context within internal function teams, external experts and working experience interacting with regulatory agencies;
9.Excellent presentation skills to a wide range of target audiences, including, but not limited to cross-functional teams, academic conferences and with regulatory meetings;
10.Capability to lead across diverse cultures with flexibility to work with global teams in different time zones;
11.Fluent in English (oral and written) is desired.
1. The Senior Medical Writer will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities, including but not limited to study protocols, patient informed consents, interim and final clinical study reports, safety update reports, Investigator brochures, and slides for internal and external presentations.
2. Conduct comprehensive literature searches to enhance their background understanding, then evaluate, analyze, and apply to clinical documents.
3. Achieve company regulatory, clinical, operational, and marketing goals and ensure the regulatory documents that he/she prepares must meet ICH, GLPs, and GCPs guidelines.
4. Review and edit documents for completeness, clarity, consistency and conformance to corporate SOPs to ensure all data and information is accurate and verifiable against source documents to confirm compliance and traceability.
5. Manage document development timelines to facilitate timely submission.
6. Attend internal/external meetings and prepare the meeting documents and meeting minutes.
7. Prepare the manuscripts for medical publications in peer-reviewed journals.
8. Contribute to writing and updating corporate SOPs, work instructions, or policies.
9. Participates in documents QC, GCP Audits and Inspections.
10. Support other functions that need medical writing support.