Chandraprakash Bora
Pune
Summary
Strategic Project Leader with 10+ years of cross-functional pharmaceutical expertise spanning Quality Assurance, Process Compliance, Clinical Research, and Pharmacovigilance. Proven architect of operational frameworks, process models, and Quality Management System (QMS) workflows designed to ensure alignment with cGMP and global regulatory requirements. Expert in managing complex external stakeholder relationships, driving continuous improvement, and enforcing rigorous data integrity standardizations across cross-functional matrix teams.
Professional medical writing expert with robust experience in creating accurate, clear, and concise medical content. Proven track record in translating complex medical research into accessible materials for diverse audiences. Strong focus on team collaboration and achieving results, adaptable to changing needs. Skilled in scientific writing, literature review, and regulatory documentation, with high level of attention to detail and reliability.
Overview
1
1
Language
11
11
years of professional experience
Work History
Medical Writer / Process Framework Architect
Syneos Health
02.2025 - 07.2026
- Architected cross-functional process frameworks and foundational models that integrated operational clinical data with execution strategies, enhancing alignment between departments.
- Evaluated and managed document lifecycle for critical foundational protocols, ensuring adherence to international regulatory standards and facilitating timely execution.
- Maintained rigorous data integrity checks across global process frameworks, ensuring compliance during complex regulatory shifts and minimizing risk exposure.
Provider Licensing Analyst
Medtigo
07.2024 - 11.2024
- Directed verification and document management protocols to guide 50+ healthcare providers through complex regulatory environments.
- Led client communications and case resolutions using CRM frameworks, enhancing cross-functional operational efficiency.
- Audited submission documents against compliance checklists, ensuring regulatory alignments with zero defects.
Manager - Senior Drug Safety Associate
Eversana
03.2023 - 04.2024
- Championed change management and risk-based pipeline evaluations, reducing process-delivery delays by 20% while monitoring financial budgets and project costs.
- Served as centralized point of contact for external partners and contract groups, aligning project milestones with corporate quality parameters.
- Led change management and risk-based pipeline evaluations, minimizing process-delivery delays by 20% while overseeing financial budgets and project costs.
- Fostered collaborative team culture by mentoring junior personnel, delivering performance feedback, and managing proactive resource planning.
Senior Drug Safety Associate
Eversana
09.2021 - 08.2022
- Led Quality Assurance team in optimizing internal processes through Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) implementation.
- Managed business process validations and performed daily case investigations to ensure compliance with domestic and international regulations.
- Directed the Quality Assurance team to spearhead internal process optimizations through advanced Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) implementation.
Senior Drug Safety Associate
Bioclinica
02.2021 - 08.2021
- Conducted quality control evaluations and managed clinical reports for international regulatory agencies, improving processing speeds by 20%.
- Reviewed and finalized scientific assessments and medical safety profiles using standardized international industry dictionaries to ensure compliance.
- Enhanced technical collaboration across functions, reducing cycle and review times by 15%.
Senior Scientific and Medical Writer
Springer Nature
04.2017 - 01.2021
- Screened scientific literature pipelines to identify critical compliance factors aligned with domestic and global safety guidelines.
- Oversaw document lifecycle of 50+ published medical items, ensuring data integrity metrics aligned with raw baseline data sources.
- Collaborated with global, matrixed technical units to implement workflow updates that enhanced reporting productivity.
Senior Process Associate
Tata Consultancy Services
05.2016 - 03.2017
- Managed end-to-end processing systems to ensure compliance with regulatory guidelines and timely submissions.
- Monitored system architectures and Safety Data Exchange Agreements (SDEAs) to support standard modifications and operational integrity.
- Self-motivated, with a strong sense of personal responsibility.
- Worked effectively in fast-paced environments.
- Skilled at working independently and collaboratively in a team environment.
Drug Safety Associate
Inventiv International Pharma Services Pvt. Ltd
03.2015 - 05.2016
- Ensured compliance with standard operating procedures (SOPs) and clinical protocols through cross-functional collaboration with clinical operations divisions.
- Coordinated regulatory submission workflows for annual assessments, product updates, and validation summaries to support timely approvals.
- Participated in external regulatory audits and compliance inspections, contributing to achievement of zero findings in verification results.
Education
Master of Pharmacy (M. Pharm) - Pharmacology
Sinhgad College of Pharmacy
Pune01-2013
Bachelor of Pharmacy (B. Pharm) - undefined
Abhinav Education Society's College of Pharmacy
Pune01-2011
Skills
Scientific writing
Clinical study reports
Regulatory documentation
Clinical documentation
Technical documentation
Scientific presentations
Manuscript preparation
QA compliance
Quality Management Systems (QMS)
Current Good Manufacturing Practices (cGMP)
RCA CAPA management
Change risk management
Document management
Scientific review
Timeline
Medical Writer / Process Framework Architect
Syneos Health
02.2025 - 07.2026
Provider Licensing Analyst
Medtigo
07.2024 - 11.2024
Manager - Senior Drug Safety Associate
Eversana
03.2023 - 04.2024
Senior Drug Safety Associate
Eversana
09.2021 - 08.2022
Senior Drug Safety Associate
Bioclinica
02.2021 - 08.2021
Senior Scientific and Medical Writer
Springer Nature
04.2017 - 01.2021
Senior Process Associate
Tata Consultancy Services
05.2016 - 03.2017
Drug Safety Associate
Inventiv International Pharma Services Pvt. Ltd
03.2015 - 05.2016
Bachelor of Pharmacy (B. Pharm) - undefined
Abhinav Education Society's College of Pharmacy
Master of Pharmacy (M. Pharm) - Pharmacology
Sinhgad College of Pharmacy