• Ensure all prepared study source documents and/or forms are in accordance to protocols, SOPs and regulations. • Assist in the review of study files upon data entry at check-in, on-study and post study procedures. • Observe, on a random basis, the clinical procedure during the conduct of studies and make sure they are performed in accordance to protocols, SOPs, GCP and regulations (i.e. Screening procedure, Subject entrance, Meals, Sample bundling, Blood collections, Vitals, ECG, etc).• Responsible for the study CRFs in accordance with the protocols and SOPs. • Ensure that all the study files after study completion are accurate and legible according to protocols, SOPs, GCP and regulations. • Provide reports on the observations/reviewed data to the relevant managers/supervisors and follow-up upon resolution.

• Conducting clinical assessments with participants with Substance Use Disorders, Depression, Thinking and Mood Disorders: scheduling, debriefing, informed consent and administering diagnostic interviews (SCID-IV) and questionnaires relating to quality of life, functioning, mood, and suicidal ideation and behaviour.• Responsible for data entry of participants including Mini International Neuropsychiatric Interview (MINI), Columbia Suicide Severity Rating Scale (C-SSRS), Montgomery–Åsberg Depression Rating Scale (MADRS), Timeline Follow Back (TLFB), Structured Clinical Interview for DSM-IV, Research Version (SCID IV - RV) on REDCap.• Conducting the Baseline orientation with the participant on Webex. • Utilized Venngage and Powerpoint to create a conference poster on study findings.• Utilizing REDCap database to enter and review participant data.• Responsible for conducting manuscript editing.

• Responsible for solving the customer inquiries.• Managing the procedure required for picking and dispensing the order to the customers. • Maintaining the record using the Microsoft excel.

• Experienced in preparation of Periodic Safety Reports including Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Reports (PADERs), Addendum to Clinical Overviews (ACOs), Corporate Addendum Reports, Safety Statements and Semi-Annual Safety Reports (SASRs) and checking of International Non-proprietary Names (INNs) for inclusion in a PSR in accordance with client requirements/conventions and Standard Operating Procedures (SOPs).• Responsible for maintaining liaison with relevant client personnel for obtaining contributions for different sections of the PSR, for raising and resolving doubts and discrepancies in the data and for coordinating review of the report.• Responsible for maintaining overall consistency of data within different sections of the PSRs.• Experienced in performing quality check of PSRs.• Experienced in international drug safety regulations including ICH guidelines, goodpharmacovigilance practice (GVP) guidelines, FDA guidelines and CIOMS.• Maintaining an awareness of global regulatory obligations and organizing workload to ensure compliance with internal and regulatory timelines Trained in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”.• Experienced in handling ERP (Enterprise Resource Planning).• Collaboration with management team to provide training to Medical Writers• Experienced in mentoring junior medical writers• Lead meeting with client and other writer to discuss regarding the authoring of reports• Managing reports based on timelines and ensuring to deliver the reports before the deadline

• Trained in preparation of PSRs including Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Reports (PADERs), Addendum to Clinical Overviews (ACOs), Corporate Addendum Reports, Safety Statements and Semi-Annual Safety Reports (SASRs) and checking of International Non-proprietary Names (INNs) for inclusion in a PSR in accordance with client requirements/conventions and Standard Operating Procedures (SOPs).• Develops and manages timelines for document development• Understanding the templates, and pre-established guidelines (eg, Standard Operating Procedures) to perform the above functions• Perform literature searches/reviews and research current guidelines• Trained in international drug safety regulations including ICH guidelines, goodpharmacovigilance practice (GVP) guidelines, FDA guidelines and CIO