Just a Guy
SENIOR MEDICAL WRITER
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About
Received and reviewed physician requisitions, assess patient history, and determine the appropriate study type/protocol. Performed polysomnographic tests using non-invasive techniques, including electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), electrocardiography (ECG). Educated the patients and their families about study procedures; ensuring comfort and cooperation.
Experience
POLYSOMNOGRAPHIC TECHNOLOGIST at PEAK SLEEP CLINIC (2026-01 – Present)
- Received and reviewed physician requisitions, assess patient history, and determine the appropriate study type/protocol.
- Performed polysomnographic tests using non-invasive techniques, including electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), electrocardiography (ECG).
- Educated the patients and their families about study procedures; ensuring comfort and cooperation.
CLINICAL ASSISTANT at PEAK SLEEP CLINIC (2026-01 – Present)
- Used Oscar PRO (EMR) for updating the daily status of appointments, patient information, faxing the consult letters etc.
- Preparation of Patient Charts in advance of clinical consultation day.
- CPAP Coordination (review of Positive Airway Pressure machine downloads, changes as needed to facilitate treatment control and compliance)
SENIOR MEDICAL WRITER at MERCK (2021-01 – 2024-12)
- Authored and reviewed clinical and aggregate safety reports including study protocols, CSRs, ICFs, PBRERs, DSURs, SERs and RMPs.
- Authored safety narratives, clinical summaries, and integrated safety reports.
- Conducted comprehensive medical and scientific literature reviews to support pharmacovigilance, clinical and regulatory submissions.
- Analyzed and synthesized clinical and safety data from multiple sources for signal detection and benefit-risk evaluation.
- Supported safety surveillance activities, including signal management and risk mitigation strategies.
- Collaborated cross-functionally with Pharmacovigilance, Regulatory Affairs, Clinical Operations, Medical Affairs, and Quality teams.
- Ensured accuracy, consistency, and regulatory compliance of safety and clinical documentation.
- Maintained document templates, version control, and document management systems.
- Assisted in regulatory responses, and safety documentation requests.
- Contributed to preparation of presentations, scientific reports, and other regulatory deliverables.
DRUG SAFETY ASSOCIATE at BIOCLINICA (2020-01 – 2021-12)
- Authored aggregate safety documents (RMP, PBRER, PSUR, ACo) for clients, ensuring scientific accuracy, consistency, and alignment with submission objectives.
- Contributed to benefit-risk assessments and risk evaluation activities by integrating findings from multiple clinical and safety sources.
- Trained and guided team members on safety writing standards, process improvements, and client-specific requirements.
- Partnered with internal teams and client stakeholders to drive document development, resolve comments, and meet project timelines.
- Managed templates, version control, and document records to support quality, traceability, and compliance.
- Drafted responses to client with clear, scientifically robust content.
Education
Bachelor of Pharmacy in Pharmacy (2011-01 – 2015-12)
Doctor of Pharmacy in Pharmacy (2016-01 – 2019-12)
Post Graduate Certification in Clinical Trials (2025-01 – 2025-10)