Are you looking for a medical writer? My extensive research experience has prepared me to be a self-motivated and effective healthcare medical writer. I have the depth of scientific knowledge to coordinate with a variety of internal (biostatisticians, CPMs, non-scientific Managers) and external (KOLs, CROs) stakeholders. I am comfortable with adapting my writing style to fit any agency guidelines, writing styles, and formatting templates, e.g. Training slide deck (PPT file) and regulatory affairs documents (WORD, PDF, eCTD dossiers).My role as a medical writer specializes in preparing regulatory submissions for an investigational medicinal product, e.g. clinical research protocol (CRP) and clinical study report (CSR). Before working as regulatory affairs medical writer, I have extensive experience in writing conducting a literature review, preparing scientific data for peer-reviewed publications, and submitting research proposals to national funding agencies, and writing press releases for communicating the science to the public audience.With my international experiences, I naturally connect well with clients from all ethnic backgrounds, and I am an independent worker and a trusted team player who can speak English, French, Mandarin, and Cantonese.STRENGTHS:➤ Knowledge on Good Clinical Practice, Clinical Research Practice, Clinical Pharmacology as evidenced by official NIH certifications, and 2 Medical Science Liaison certifications on knowledge of drug life cycle offered by FromScienceToPharma online training.➤ Technical and Scientific Writing expertise. I have published a total of 15 research articles, 18 conference presentations, 3 antibodies validation reports, 1 review paper, 1 US patent.➤ Relentless Communicator, as evidenced by over 10 regional and international conference presentations, 1 poster award, 1 Teaching-excellence Award, 50+ youtube videos. ➤ Strong Consensus Builder in a multifunctional environment, I have worked with over 50 scientists, and completed collaborative and Interdisciplinary projects. When I am not at work, you will find me networking with PhD alumni, mentoring PhD students, preparing video contents for my YouTube channel (PhDCoffeeTime), it is a passion-project to serve the scientific community with my experience and knowledge. I am from Hong Kong and currently based in Knoxville (Green Card holder).
Freelance
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Freelance Medical WriterFreelance Jul 2022 - PresentCurrently 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).
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Freelance Medical WriterFreelance Mar 2022 - Jul 2022I support a variety of medical writing projects, including CSR, Protocol, IB, MAA, scientific publications, and abstracts, content QC, and data QC.
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Medical WriterVoisin Consulting Life Sciences (Vcls) Nov 2021 - Apr 2022Paris, Paris, FrI 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 -
Medical Writer & Regulatory Affairs ExecutiveAb Science Jan 2021 - Sep 2021Paris, FrI 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 -
Certified Knowledge On The Role Of Msl, Clinical Research Practices, And Clinical PharmacologyFrom Science To Pharma (Fstp) - Msl Global Online Training Jun 2019 - Jan 2021Sydney, AuI 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/): -
Postdoctoral Researcher • Pharmaceuticals • Biostatistics • Molecular Biology • International TeamInstitut Francais De Recherche Pour L'Exploitation De La Mer - Ifremer Nov 2018 - Apr 2020GABA 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 -
Postdoctoral Research Associate • Distinguished Postdoc Award • Patent • Tech Transfer • MentoringClemson University Feb 2015 - Oct 2018Clemson, 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 -
Postdoctoral Researcher ➤Organized International Conference ➤Interdisciplinary & Multicultural TeamThe University Of Hong Kong Jan 2014 - Sep 2014Hong Kong, Pokfulam, HkKey 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 -
Morrison Hall Resident TutorThe University Of Hong Kong Jan 2014 - Sep 2014Hong Kong, Pokfulam, HkMental health first-aider and counselorI completed 9 months of services as a residential tutor for HKU students.
Vera Bin San Chan, Ph.D. Skills
Vera Bin San Chan, Ph.D. Education Details
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The University Of Hong KongBiological Sciences -
The University Of Hong KongBachelor Of Science - Bs
Frequently Asked Questions about Vera Bin San Chan, Ph.D.
What company does Vera Bin San Chan, Ph.D. work for?
Vera Bin San Chan, Ph.D. works for Freelance
What is Vera Bin San Chan, Ph.D.'s role at the current company?
Vera Bin San Chan, Ph.D.'s current role is Regulatory Medical Writer | Authorized to work for any US employer | Host of PhDCoffeeTime.
What schools did Vera Bin San Chan, Ph.D. attend?
Vera Bin San Chan, Ph.D. attended The University Of Hong Kong, The University Of Hong Kong.
What skills is Vera Bin San Chan, Ph.D. known for?
Vera Bin San Chan, Ph.D. has skills like Leadership, Presentation Skills, Transmission Electron Microscopy, R, Clinical Trials, Public Speaking, Interdisciplinary Collaboration, Cell Biology, Agile Project Management, Materials Science, Microscopy, Neuroscience.
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