Nadia Lin

- Medical Writer/Medical Scientist in CRO company (about 2 years)

<Medical Writer>
* CDE consultation
* Accomplished and reviewed proficiently phase 0/I/II/III/IV Clinical Study Protocols, Case Report Forms, Clinical Study Reports, and regulations-led submission package in multidisciplinary area.
- 1 Retrospective Chart Review study in oncology area, 4 Case Report Forms (draft/review) in oncology/infection area, 13 Clinical Study Protocol (1 pivotal study for the registry approval of the medical device), and 16 Clinical Study Report.
* Processed the science-driven communication skill with Principal Investigator and internal Clinical Operation team.
* Generated the Bridging Study Evaluation of a new small molecule inhibitor in hematology area and exceeded target goal.
* Assessed and designed the 23 evaluation cases/presentation of PK/PD/BE for medications to our diverse customers based with complex needs (e.g., new strength /formulation, injections), and fully meet the requirements from TW/CN/JP/MY countries.
* Executed and coordinated the medical monitor / medical coding / pharmacovigilance tasks.
Area: drug/medical device/gene testing/regulatory affair/PV

<Others>
* Research report of Taiwan's Comprehensive Medical Technology Assessment of The Development and Design (2016)

*Lin Y-C, Lee T-C, Chen C-Y, Lin S-J, Hwang S-J, Lin M-Y (2020) Effectiveness of antiresorptive medications in women on long-term dialysis after hip fracture: A population-based cohort study. PLoS ONE 15(9): e0238248. https://doi.org/10.1371/journal.pone.0238248

Medical Writer
Master of Science in Clinical Pharmacy
Bachelor of Science in Pharmacy
Registered Pharmacist

Clinical Study Protocol / Informed Consent Form / Clinical Study Report / Package Insert / Instruction for Use / Investigational's brochure / Adverse Events / Clinical Labeling / e Clinical Outcome Assessment / Clinical Trials / Medical Devices & Software / Pharmaceuticals / Regulatory Affairs / Other Life Sciences Content
/ Other submission package / medical or clinical research-related documents (Chinese-English translation)

pharmaceutical company/physicians