Dr. Kausik Ganguly (Ph.D.)
Kolkata
Summary
Dynamic medical writing manager with extensive experience at Medclin Research Pvt. Ltd, excelling in regulatory documentation and quality control. Proven ability in protocol development and stakeholder coordination, ensuring compliance and timely project delivery. Adept at mentoring teams and enhancing processes, contributing to impactful scientific publications and successful clinical trials.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Manager, Medical Writing
Medclin Research Pvt. Ltd
Kolkata
12.2024 - Current
- Authored and reviewed regulatory and scientific clinical documentation including Clinical Study Protocols, Case Report Forms (CRF), Informed Consent Documents (ICD), Clinical Study Reports (CSR), Statistical Analysis Reports (SAR), and manuscripts as per regulatory compliance
- Led quality assurance and peer review processes for multi-document clinical projects, implementing systematic quality control checks against pre-defined SOPs and project-specific checklists to ensure 100% regulatory adherence
- Coordinated multi-stakeholder clinical research projects with authors, reviewers, journal editors, production editors, proofreaders, and external clients; managed parallel assignments while maintaining strict adherence to timelines and quality standards
- Developed study-related risk management and safety plans including safety monitoring protocols and risk mitigation strategies for clinical trial operations
- Conducted presales activities and feasibility assessments for CRO deliverables including Concept Notes, technical presentations, and Feasibility Questionnaires
- Provided medical/scientific training and mentoring to team members on clinical research topics and medical writing best practices; contributed to process improvement initiatives
- Contributed the publication of following peer-reviewed scientific articles:
Analyst, Systematic Reviews
Indence Health @ Indence Research Private Limited
09.2024 - 11.2024
- Conducted end-to-end evidence synthesis projects including protocol development, comprehensive systematic database searching, study selection, data extraction, risk-of-bias assessment, and evidence tabulation for SLRs and TLRs in clinical and health economics domains
- Led Real-World Evidence (RWE) initiatives synthesizing published RWD from registries, claims databases, EHR-based studies, and pragmatic trials to characterize epidemiology, comparative effectiveness, safety, and health economic outcomes
- Authored high-quality scientific deliverables including structured evidence reports, slide decks, manuscripts, and white papers for global pharmaceutical and medical device clients
- Performed quantitative and qualitative data synthesis and supported interpretation of complex clinical and economic data to inform evidence-based decision-making
Senior Medical Writer
THB c/o Sekhmet Technologies Pvt Ltd
09.2023 - 07.2024
- Authored clinical regulatory documentation (Clinical Study Protocols, CRF, ICD, CSR, SAR) and scientific manuscripts for multiple concurrent therapeutic area projects in compliance with ICH-GCP guidelines and FDA/EMA regulatory requirements
- Conducted comprehensive peer review and quality control of clinical documents prepared by colleague writers, identifying and resolving regulatory compliance issues and documentation inconsistencies
- Coordinated with internal stakeholders and external partners including principal investigators, study sponsors, clinical monitors, and journal editors; actively participated in client meetings and technical discussions for project scope and deliverable specifications
- Developed safety monitoring and risk mitigation plans for clinical trials and managed study-related regulatory documentation
- Contributed to presales deliverables including Approach/Concept Notes, technical decks, and feasibility questionnaires for pharmaceutical and medical device clients
- Contributed the publication of following peer-reviewed scientific articles:
ICMR-Research Fellow (Post-Doctoral Fellow)
Institute of Post-Graduate Medical Education & Research (IPGME&R)
Kolkata
07.2022 - 08.2023
- Managed multi-centric epidemiological research in ICMR's Network of Pulmonary Fibrosis (INPF) involving data curation, maintenance, and quality control from ILD-affected populations
- Conducted scientific writing preparing review articles and original research manuscripts for peer-reviewed publication; implemented rigorous peer review processes
- Facilitated multi-disciplinary collaboration serving as key liaison between physicians, patients, and healthcare centers; organized weekly multidisciplinary case discussions (MDD)
- Performed clinical assessments including Pulmonary Function Tests, DLCO measurements, and 6-minute walking tests per ATS protocols
- Developed research grants and hypothesis based on clinical observations and multidisciplinary discussions with medical experts
- Managed scientific content preparation and portal uploads to ICMR's centralized research database
Senior Research Fellow / Research Fellow (Multiple Fellowships)
University of Calcutta
Kolkata
06.2013 - 06.2022
- Positions Held: Senior Research Fellow (CSIR-SRF Direct) | April 2017 – January 2019, Senior Research Fellow (University Research Fellowship) | June 2015 – April 2017, Senior Research Fellow (DST-PURSE-II) | February 2020 – January 2021, Project Assistant (DST-SERB) | March 2021 – June 2022, Junior Research Fellow (University Research Fellowship) | June 2013 – June 2015
- Research Focus: Human genetic rare diseases including oculocutaneous albinism, haemophilia, and skin pigmentation disorders
- Managed and trained graduate and undergraduate researchers in molecular and cell biology techniques for human disease investigation; developed SOPs and training materials
- Authored and peer-reviewed scientific manuscripts (review articles and original research) for publication in high-impact journals including Archives of Dermatological Research (Springer Nature)
- Conducted bioinformatic analysis and variant prioritization developing novel computational methods for functional annotation of single nucleotide variants (SNVs) in GWAS data
- Communicated complex scientific findings to diverse audiences including health workers and community stakeholders; fostered collaborations with rural healthcare workers
- Managed research timelines and resource allocation identifying plans and checkpoints; communicated project progress to stakeholders
- Created and validated novel bioinformatic methodology for SNV prioritization and pathogenicity assessment, resulting in peer-reviewed publication
Education
Doctor of Philosophy (Ph.D.) - Genetics
University of Calcutta
Kolkata, West Bengal, India07.2022
Master of Science (M.Sc.) - Zoology
University of Calcutta
Kolkata, West Bengal, IndiaBachelor of Science with Honours (B.Sc. Hons) - Zoology
University of Calcutta
Kolkata, West Bengal, IndiaSkills
- Protocol Development
- ICH-GCP Compliance
- Statistical Analysis Reports (SAR)
- Clinical Study Reports (CSR)
- Case Report Forms (CRF)
- Informed Consent Documents (ICD)
- Regulatory Document Writing
- Medical Writing
- Manuscript Development
- Clinical Documentation
- Scientific Communications
- Quality Control
- Peer Review
- Document Management
- SOPs
- Regulatory Guidelines
- Systematic Literature Reviews (SLR)
- Targeted Literature Reviews (TLR)
- Real-World Evidence (RWE) Analysis
- Data Synthesis
- Epidemiological Research
- Comparative Effectiveness Studies
- Statistical Data Interpretation
- Project Management
- Stakeholder Coordination
- Client Engagement
- Process Improvement
- Team Training
- Mentoring
- Cross-functional Collaboration
- Attention to Detail
- Scientific Writing
- Microsoft Office
- Referencing Software
- Literature Database Management
- Clinical Study Protocols
- Study Summaries
- Scientific Abstract Writing
- Regulatory Compliance Documentation
- Protocol Synopsis
- Clinical Research Ethics
- Meta-analysis
- Quantitative Synthesis
- Biosimilar Development
- Gene Therapies Development
- Vaccine Development
- Clinical Trial Design Methodologies
- Therapeutic Area Expertise
- Drug Development Processes
- Disease Epidemiology
- Clinical Research Methodology
- Office Suite Proficiency
- PubMed
Honours And Awards
- Awarded by Medclin Research Pvt. Ltd., 2025, for my contribution in providing 'Last minute support' in project planning and execution of Consensus Statement and KAP survey studies (two)
- ICMR-SRF Selection, 2022, Multi-center epidemiological study, ICMR's Network of Pulmonary Fibrosis (INPF)
- DST-SERB Project Fellow, 2021, Human Rare Genetic Disorder research, University of Calcutta
- DST-PURSE Senior Research Fellow, 2020, University of Calcutta
- CSIR Senior Research Fellow (Direct), 2017–2019, Council of Scientific and Industrial Research
- University Research Fellowship, 2013–2015, University of Calcutta
- CSIR-UGC-NET (Lectureship) Qualification, 12/01/12 and 06/01/13, Two-time qualifier
Publications And Scientific Contributions
Contributed as Medical/Scientific Writer:
- Bal, A., Vaidya, S., Parakh, R., et al. (2023). Assessment of chronic wound patients' journey in India: perspectives of healthcare professionals and patients. Wounds International.,
- Shah, N., Ghosh, A., Kumar, K., Dutta, T., & Mahajan, M. (2024). A review of safety and immunogenicity of a novel measles, mumps, rubella (MMR) vaccine. Human Vaccines & Immunotherapeutics, 20(1).,
- Agarwal, N., Gupta, N., Nishant, H.S.S., Dutta, T., & Mahajan, M. (2024). Typhoid Conjugate Vaccine: A Boon for Endemic Regions. Cureus, 16(3):e56454. doi: 10.7759/cureus.56454.,
- Shetty SH, Amarnath SS, Karmakar A, Mitra M, Madkholkar N, Pawar R, Sharma A. Evaluation of the Prevalence, Trends, and Correlates of Low Back Pain in India: A Retrospective Cross-Sectional Study. Cureus. 2025 May 5;17(5).,
- Mankar SV, Patel C, Chavan A, Modi R, Sarangi L, Tripathi VN, Dash DK, Narayan JP, Bandgar S, Kumar NR, Gill VK, Kakkar MK, Mitra M, Daultani P, Mittal R, Maithal K, Kansagra K, Parmar DV, Dutta T, Mahajan M, Desai S. An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participants. Hum Vaccin Immunother. 2025 Dec;21(1):2550085.,
Contributed as Researcher/Scientific Writer:
- Sengupta, M., Sarkar, D., Ganguly, K., et al. (2015). In silico analyses of missense mutations in coagulation factor VIII. Haemophilia, 21(5):662–9.,
- Ray, K., Sengupta, M., Ganguly, K. (2016). Oculocutaneous Albinism. Atlas of Genetics and Cytogenetics in Oncology and Haematology, 20(6):352–8.,
- Ganguly, K., Dutta, T., Samanta, S., et al. (2017). C10ORF11 is Unlikely to have a Major Contribution towards OCA Pathogenesis in Southern and Eastern India. Journal of Human Biology & Health Education, 1(1):1–4.,
- Roy, S., Ganguly, K., Pal, P., et al. (2018). Influence of Apolipoprotein E polymorphism on susceptibility of Wilson disease. Annals of Human Genetics, 82(2):53–9.,
- Ganguly, K., Saha, T., Saha, A., et al. (2019). Meta-analysis and prioritization of human skin pigmentation-associated GWAS-SNPs using ENCODE data-based web-tools. Archives of Dermatological Research, 311(3):163–71.,
- Ganguly, K., Dutta, T., Saha, A., et al. (2020). Mapping the TYR gene reveals novel and previously reported variants in Eastern Indian patients. Annals of Human Genetics, 82(3).,
- Sengupta, D., Banerjee, S., Mukhopadhyay, P., et al., Ganguly, K. (2020). A meta-analysis and in silico analysis of polymorphic variants conferring breast cancer risk in the Indian subcontinent. Future Oncology, 16:2121–42.,
- Pyne, T., Ghosh, P., Dhauria, M., Ganguly, K., et al. (2022). Prioritization of human well-being spectrum related GWAS-SNVs using ENCODE-based web-tools. Journal of Psychiatric Research, 145:92–101.,
- Ganguly, K., Sengupta, D., Sarkar, N., et al. (2022). Comprehensive in Silico Analyses of Single Nucleotide Variants of Human Pigmentation. Proceedings of the Zoological Society, 1–20.,
- Dutta, T., Mitra, S., Saha, A., Ganguly, K., et al. (2022). A comprehensive meta-analysis and prioritization study to identify vitiligo associated coding and non-coding SNV candidates. Scientific Reports, 12(1):1–12.,
- Sadhukhan, S., Paul, N., Ghosh, S., et al., Ganguly, K. (2022). Analysis of DNMT1 gene variants in progression of neural tube defects. Bioscience Reports, 42(12):BSR20220998.,
- Sengupta, D., Mukhopadhyay, P., Banerjee, S., Ganguly, K., et al. (2023). Identifying polymorphic cis-regulatory variants as risk markers for lung carcinogenesis in tobacco smokers from eastern India. Scientific Reports, 13(1):1–19.,
- Ganguly, K., Dutta, T., Ganguli, S., et al. (2023). Common structural attributes of tyrosinase variants and endoplasmic reticulum retention: a homology modelling study with 45 variants. Proceedings of the Indian National Science Academy, 89:825–836.,
- Dutta T, Ganguly K, Saha A, Sil A, Ray K, Sengupta M. Identifying genetic defects in oculocutaneous albinism patients of West Bengal, Eastern India. Molecular Biology Reports. 2024 Dec;51(1):818.,
- Saha T, Ganguly K, Bhowmick B, Mitra S, Bhattacharyya A, Dutta T, Sengupta M. Knowledge of NUMTs and mitochondrial DNA specific primer designing is of utmost importance to avoid misidentification of heteroplasmic mutations. The Nucleus. 2024 Dec;67(3):579-87.,
- Dhauria M, Pyne T, Nandagopal K, Chakraborty I, Ganguly K, Sengupta D, Mondal S, Sengupta M, Das M. The SNAP25 gene emerges as a pivotal player in shaping well-being levels not only among Indians but also on a global scale. The Nucleus. 2025 Jan 15:1-3.,
- Paul N, Sadhukhan S, Chatterjee S, Das A, Munian D, Ganguly K, Bankura B, Ghosh K, Ghosh S, Das M. Novel Variants of IGF2 Gene Are Linked With Neural Tube Defects‐An In Silico to Clinical Approach in West Bengal, India. Birth Defects Research. 2025 Jan;117(1):e2428.,
- Mitra S, Sharma P, Ganguly K. Oral Candidiasis in COVID-19 Patients Under Critical Care Involving Non-albicans Candida Species Alongside Candida albicans. Cureus. 2025 Jul 14;17(7):e87949.
Regulatory Training And Certifications
- ICH GCP E6 (R3) — Good Clinical Practice Training, Current
- NIDA CTN GCP — National Institute on Drug Abuse Clinical Trials Network, 09/12/26
- Advanced Course on Clinical & Genetic Epidemiology, National Institute of Biomedical Genomics, Society for Applied Studies, Indian Statistical Institute, 09/01/19
- Virtual Course on Vaccine Production: Basics, Pitfalls and Troubleshooting, Serum Institute of India & Pune Knowledge Cluster, 02/01/21
- Skill Development Program: Cryo-EM Sample Optimization and 3D Structure Reconstruction, CSIR-IICB, Government of India, 03/01/21, IICB/21-22/SDP/IICB-CEM/0004
- Hands-on Next Generation Sequencing, Analysis & Applications, Trans-disciplinary Health Sciences (TDU) & Bengaluru Genomics Centre, 02/01/19
- Multicolor Flow Cytometry Experimental Design and Data Analysis, Flowcytometry Solutions, Jaipur, 08/01/20
- DNA Barcoding: Power and Practice, University of Calcutta & Paul Hebert Centre for DNA Barcoding, 12/01/15
Technical Skills
Clinical Study Protocols, Case Report Forms (CRF), Informed Consent Documents (ICD), Clinical Study Reports (CSR), Statistical Analysis Reports (SAR), Study Summaries, Manuscript development and preparation for peer-reviewed journals, Scientific abstract and response document writing, Quality control, peer review, and document standardization, ICH-GCP E6(R3) and regulatory compliance documentation, ICH-GCP (Good Clinical Practice) guidelines — E6(R3) trained, FDA, EMA, and other international regulatory requirements, Clinical trial disclosure commitments and reporting, Protocol synopsis and lay summaries, Regulatory submission preparation and management, Clinical research ethics and informed consent procedures, Adverse event reporting and pharmacovigilance, Document control, versioning, and audit trail management, Systematic Literature Reviews (SLR) methodology, Targeted Literature Reviews (TLR) protocols, Real-World Evidence (RWE) analysis and synthesis, Comparative effectiveness research, Epidemiological data analysis and interpretation, Meta-analysis and quantitative synthesis, Statistical data interpretation and presentation, Biosimilar development for Cancer therapy, checking its efficacy and safety, Development of Gene therapies for Rare diseases, Vaccine development, immunogenicity, and positioning, Clinical trial design methodologies and phases, Therapeutic area expertise: respiratory, genetics, infectious disease, immunology, Pharmacology and drug development processes, Disease epidemiology and disease burden assessment, Clinical research methodology and study design, Office Suite: Microsoft Word, Excel, PowerPoint, Literature & Data Management: PubMed, BioDesk, reference management software, Statistical Tools: R programming, data analysis packages, Research Management: Clinical trial management systems, study tracking platforms, Data Systems: Electronic data capture (EDC) systems, EHR platforms, database management, Bioinformatics: GWAS databases, variant annotation tools, Swiss-PDB-viewer, ENCODE tools, Molecular Biology: DNA/RNA isolation, PCR, RFLP, Sanger sequencing, gel electrophoresis, Microbiology: Bacterial culture, transformation, plasmid DNA isolation, Cell Biology: Animal cell culture, transfection, protein isolation and quantification, Protein Methods: SDS-PAGE, co-immunoprecipitation, protein analysis, Bioinformatics: Variant prioritization, pathogenicity assessment, structural analysis
Languages
English
Proficient (C2)
C2
Bengali
Proficient (C2)
C2
Hindi
Intermediate (B1)
B1
Certification
NIDA CTN GCP
Timeline
Manager, Medical Writing
Medclin Research Pvt. Ltd
12.2024 - Current
Analyst, Systematic Reviews
Indence Health @ Indence Research Private Limited
09.2024 - 11.2024
Senior Medical Writer
THB c/o Sekhmet Technologies Pvt Ltd
09.2023 - 07.2024
ICMR-Research Fellow (Post-Doctoral Fellow)
Institute of Post-Graduate Medical Education & Research (IPGME&R)
07.2022 - 08.2023
Senior Research Fellow / Research Fellow (Multiple Fellowships)
University of Calcutta
06.2013 - 06.2022
Doctor of Philosophy (Ph.D.) - Genetics
University of Calcutta
Master of Science (M.Sc.) - Zoology
University of Calcutta
Bachelor of Science with Honours (B.Sc. Hons) - Zoology
University of Calcutta