Shirene Singh
Mississauga,Canada
Summary
Certified Clinical Research and Regulatory Affairs Professional with a background in life sciences. Previous regulatory affairs and clinical research internship experience; able to support regulatory submissions and clinical development. Knowledge of drug development, clinical trial design and procedures. Well-versed in ICH/GCP guidelines and FDA regulations. Medical writing experience with an understanding of study protocols, ICF, study reports, CRF, eCRFs, SOPs and ALCOA principles. Experience with project management tools like Excel and ClickUp; willing to learn new technologies. Strong organizational, coordination and prioritization skills with proven ability to manage community-based and industry projects.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Pharmacy Assistant Volunteer
Pharmasave Pharmacy
04.2025 - Current
- Help reduce wait times for patients by consistently prioritizing tasks based on urgency and pharmacist directives
- Enhance patient satisfaction by efficiently processing prescriptions and maintaining accurate records using the Kroll Pharmacy Software
- Maintain open lines of communication with pharmacists to promptly address any concerns related to medication orders
Vaccination Clinic Flow Monitor Volunteer
Region Of Peel
06.2023 - Current
- Greet patients, monitor line-ups, confirm appointments, ensure clinic eligibility criteria have been met, direct patients to registration
- Facilitate crowd control, coordinate clinic flow, determine accessibility needs and vaccinations required
Regulatory Affairs Intern
Johnson & Johnson Innovative Medicine
06.2024 - 10.2024
- Assisted the RA department to improve critical departmental processes by collaborating with a team of 7 people including 3 directors to develop a playbook, which was implemented across the LOC
- Collaborated within a team environment to meet regulatory submission deadlines, resulting in the successful submission of regulatory documents for 4 different drug products
Medical Writer
Medivizor Inc
01.2021 - 06.2024
- Analyzed, interpreted and summarized clinical trial data to promote patient health literacy and decision-making by collaborating with senior medical writers, leading to 157 clinical summaries
Lecturer-Immunology
The University of the West Indies
08.2017 - 01.2020
- Delivered over 25 lectures and laboratory sessions to 60+ medical students for an undergraduate immunology course with over a 95% pass rate
- Chaired a committee responsible for the delivery of 6 medical educational outreach lectures at community clinics and 3 community-based research projects
- Maintain accurate records of student attendance, participation, assignments and grades while adhering to strict confidentiality standards
Assistant Lecturer in Virology
The University of the West Indies
09.2008 - 12.2011
- Used PowerPoint to give lecture presentations to 50+ medical students and adapted lectures based on student feedback and individual learning styles
- Maintained accurate records of student attendance, participation, assignments and grades while adhering to strict confidentiality standards
Education
Post-Graduate Certification - Regulatory Affairs
Sheridan College
Mississauga, ON10.2024
Certificate - Clinical Research Associate
International Clinical Research Academy (ICRA)
Montréal, QC09.2022
Doctor of Philosophy - Pathobiology
University of Guelph
Guelph, ON06.2016
Skills
- Strong organizational skills
- Strong attention to detail
- Multitasking proficiency
- Effective coordination & prioritization
- Technical & Software
- Written and verbal communication
- Project coordination
- Time management
- Medical writing
- Cross-functional collaborations
- Ability to work independently
- Client-focused
LANGUAGES
English - Native or Bilingual
French - Elementary
Spanish - Elementary
Affiliations
Canadian Association of Professionals in Regulatory Affairs (CAPRA)-Member since 2024
Certification
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2: CORE) in 2022; CITI Program: Summit-Participant Recruitment and Retention in 2025
Timeline
Pharmacy Assistant Volunteer
Pharmasave Pharmacy
04.2025 - Current
Regulatory Affairs Intern
Johnson & Johnson Innovative Medicine
06.2024 - 10.2024
Vaccination Clinic Flow Monitor Volunteer
Region Of Peel
06.2023 - Current
Medical Writer
Medivizor Inc
01.2021 - 06.2024
Lecturer-Immunology
The University of the West Indies
08.2017 - 01.2020
Assistant Lecturer in Virology
The University of the West Indies
09.2008 - 12.2011
Certificate - Clinical Research Associate
International Clinical Research Academy (ICRA)
Doctor of Philosophy - Pathobiology
University of Guelph
Post-Graduate Certification - Regulatory Affairs
Sheridan College
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