Vera Bin San Chan, Ph.D. Email & Phone Number

Currently specialized in the preparation of regulatory documents in human medicine, including CSR, protocol, agency response, and Clinical Modules of MAA.I am now a green card holder, interested in regulatory medical writing opportunities in the US (full-time/ freelance).

I support a variety of medical writing projects, including CSR, Protocol, IB, MAA, scientific publications, and abstracts, content QC, and data QC.

Paris, Paris, Fr

I was the Medical Writer of VCLS in the Paris Office, my role included the following:♦ supported the authoring, reviewing, and delivering of high-quality clinical sections of a wide variety of regulatory documents, such as EMA Scientific Advice, marketing authorization application (MAA) briefing documents, Clinical summary (Module 2.5, 2.7), and CSRs (module 5) of MAA in a timely manner. ♦ performed relevant literature searches and present the scientific information in an accurate and concise form to assist regulatory strategies. ♦ liaised with international project teams (primarily in the UK, France, and India) on medical writing deliverables and project timeline

Paris, Fr

I was involved in Medical Writing (50%) and providing Regulatory Affairs (50%) assistance. Medical Writing (Oncology)♦ Medical writing of all types of regulatory and clinical study documentation including clinical study reports (CSR), clinical summaries, narratives, Investigators’ Brochures (IB), and clinical study protocols.♦ Worked with Biostatisticians to communicate clinical data accurately in a compliant manner♦ Simultaneously managed several projects, met tight deadlines♦ Quality control (QC) for other medical writing deliverables in an organized, communicative, and timely manner♦ Therapeutic Areas included Pancreatic Cancer, Asthma, Alzheimer's diseaseRegulatory Affairs:♦ Assisted the submission of annual reports (IB and DSUR), suspected unexpected serious adverse reaction(SUSAR) reports to health authorities in EU (VHP submission), UK (MHRA), and US (FDA) for Pharmacovigilance (PV) team♦ Coordinated regulatory activity with Contract Research Organizations (CROs) to assist the regulatory need of studies outside of EU, UK, and the US.♦ Provide rapid assistance and guidance to support Clinical Trial Applications (CTAs) for Clinical Project Managers (CPMs) teams♦ Created and maintained clear and compliant documentation (Excel trackers, email records, Acknowledgement of Receipts/AoRs) for all regulatory submission/review process

Sydney, Au

I have certified knowledge from the FromSCIENCEtoPHARMA training program on ♦ Pharmaceutical product life cycle, the value of Medical Affairs in drug development ♦ How to perform the scientific role of MSL to engage internal and external stakeholders ♦ How to communicate clinical data in a compliant manner according to ICH, FDA guidelines, and the Sunshine Act Introduction to the Principles and Practice of Clinical Research 2019-2020 (Exam score: 85%) ♦ FDA guideline and regulations of Drug and Biologics Developments ♦ Basic Principles and Ethical considerations of Clinical Trial ♦ Randomization, Blinding, Power Analysis, Kaplan and Meier Survival Analysis ♦ Cost and Budget, Project management and Data Quality Assurance in Clinical TrialsPrinciples of Clinical Pharmacology 2019-2020 (Exam score: 80%) ♦ Pharmacokinetics, Pharmacodynamics (PKPD) and Pharmacogenetics of Drugs and Biologics ♦ Preclinical Phase 0, Phase 1, Phase 2, Phase 3, and Post Market Surveillance Phase 4 ♦ Drug Labeling and Adverse Event Reporting (MedDRA)Further certified knowledge from NIH online training program (https://ocrtraining.cit.nih.gov/):

GABA pathway • anti-epilepsy drugs • Carbamazepine • Neurobiology • Video and Image analysis • Biostatistics • Programming with R, Python, ImageJMajor accomplishment• Led undergraduate and masters project• Published 4 peer-reviewed papers • Propose international collaboration ➤ Euro$3800 to conduct visiting research in AustraliaGained skills in life sciences: RNA purification and quantification• Molecular biology ➤ qPCR ➤ bioinformatics• Video and Image analysis ➤ Macro script programming ➤ image J• Biostatistics programming with R• cultivation of a model organism ➤ full life-cycle

Clemson, Sc, Us

♦♦♦ 2018 CUPDA Distinguished Postdoc Award by Clemson University♦♦♦Key Accomplishments:• 6 papers in peer-reviewed journals ➤ Biofouling • Frontiers in Marine Science • Journal of Structural Biology • JoVE • PLoS ONE• Executed innovative research ➤ one patent awarded in 2016 (WO2016191200A1)• Conference and Research Site Visit ➤ Hong Kong • Japan • Norway • CA • MA • FL • NC • NV • OHProject management and leadership experience:• Propose, and Manage $7000 research project• Interviewed and Recruit student on a research project• Led a team of 6 students• Highly rated undergraduate course by undergraduate studentsKey transferable skills gained:• Communication on phone, video, and conference • US Patent and Tech transferKey research techniques gained:• Light and electron Microscopy • CLSM • SEM • TEM • EBSD • FIB-TEM • Digital holographic microscopy (DHM) • Phosphorescence Lifetime Imaging (PLIM) • Fluorescence Lifetime Imaging (FLIM) • Antibody validation • Cell culture • Protein purification • western blotting • Antibody • Histology • Ultramicrotome • Organelle observation

Hong Kong, Pokfulam, Hk

Key research skills gained:• CT scan • Image analysis • Interdisciplinary Research ➤ Keynote presentation in Japan JpGUMentoring and Leadership experience• Mentored 2 graduate students ➤ 4 peer-reviewed papers published• Workshop organization ➤ 6 regional collaborations and 5 international collaborations

Hong Kong, Pokfulam, Hk

Mental health first-aider and counselorI completed 9 months of services as a residential tutor for HKU students.

Doctor Of Philosophy (Ph.D.), Biological Sciences

Bachelor Of Science - Bs