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Albert C
Associate Medical Manager – Medical Writing
Medical Writing
Albert C. is an experienced Medical Writing professional with 10+ years in clinical and regulatory documentation for pharmaceuticals and medical devices. He specializes in authoring CERs, PMS/PSUR/PMCF reports, and Risk Management deliverables under MDR, MEDDEV Rev. 4, ICH, FDA, and EMA guidelines. Skilled in literature research, data evaluation, and cross-functional collaboration, she leads writing projects end-to-end while mentoring teams and ensuring regulatory accuracy and compliance.
FORMERLY AT
Pfizer Products India Pvt. Ltd.
LOCATION
Chennai
AVAILABILITY
Full-time
Skills
CER
Clinical Monitoring
Data Review
Embase
MDR/ICH/FDA/EMA compliance
Medline
OvidSP
PMCF
PSUR
PubMed
Regulatory Compliance (MDR)
Risk Management Documentation
Study Coordination
Work Experience
Lead Engineer – Medical Devices
HCL Technologies
May 2018 – June 2020
- Led PMS and PMCF documentation teams supporting EU MDR compliance.
- Authored CERs and PSURs; reviewed risk management documents and clinical investigation protocols.
- Developed SOWs, managed project trackers, and trained new team members on domain knowledge.
TECHNOLOGIES
CER, PSUR, PMCF, Risk Management Documentation, Regulatory Compliance (MDR)
Senior Clinical Process Specialist
IQVIA, Mumbai
August 2017 – May 2018
- Supported centralized monitoring activities and clinical process management.
- Coordinated projects, worked with site teams, and reviewed clinical study data for quality and completeness.
TECHNOLOGIES
Clinical Monitoring, Data Review, Study Coordination
