SAYANTI SAU
Bangalore
Summary
Experienced and results-driven Senior Medical Writer with over 8 years of experience in regulatory medical writing, clinical trial disclosure, and pharmacovigilance. Proficient in authoring protocols, informed consent forms (ICFs), clinical study reports (CSRs), and handling EMA Policy 0070 PRCI submissions. Demonstrated success in leading cross-functional teams and managing large-scale writing projects. Skilled in stakeholder communication, regulatory compliance, and continuous process improvement.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Medical Writer II
Parexel International
Bangalore
01.2023 - Current
- Lead multiple regulatory writing and disclosure projects, acting as Partnership Operational Lead; authored and reviewed protocols, ICFs, CSRs, and disclosure documents; delivered EMA Policy 0070 and PRCI submissions in compliance with global regulations; mentored new writers, facilitated onboarding, and internal training; developed SOPs and client-specific guidelines; managed timelines, addressed scope changes, resourcing and resolved cross-functional issues.
Medical Writer I
Parexel International
Bangalore
07.2021 - 02.2023
- Client liaison for project deliverables, timelines, and expectations; authored Plain Language Summaries, Lay Protocol Synopses, and Redaction packages; reviewed SAPs and mock outputs to ensure disclosure alignment; led training for new joiners, and supported process improvements.
Senior Drug Safety Associate
Novo Nordisk Service Centre
Bangalore
01.2021 - 06.2021
- Conducted literature surveillance and coordinated with affiliates for compliance, served as an EDC superuser, and provided support for NIS process management. Reviewed SOPs, protocols, TVP, and performed AE reconciliation.
Disclosure Medical Writer
Novo Nordisk Service Center
Bangalore
02.2020 - 12.2020
- Authored redacted documents and lay summaries for public disclosure, and submitted results to global registries, including ClinicalTrials.gov and EudraCT.
Drug Safety Associate II
Accenture Operations Pvt. Ltd
Bangalore
05.2018 - 02.2020
- Prioritized and reviewed case safety reports in a global database, trained new hires, and contributed to quality automation projects.
Medical Service Analyst
Accenture Operations Pvt. Ltd
Bangalore
07.2015 - 05.2018
- Processed pharmacovigilance cases and reports, conducted MedDRA coding and narrative writing, mentored peers, and ensured compliance with SOPs.
Education
M.Pharm - Pharmacology
Rajiv Gandhi University of Health Sciences
Bangalore01.2015
B.Pharm -
Rajiv Gandhi University of Health Sciences
Bangalore01.2012
Skills
- Regulatory writing
- Clinical trial disclosure
- Project management
- Client communication
- Cross-functional collaboration
- Training facilitation
- Team mentorship
- Effective communication
- Multitasking Abilities
- Teamwork and collaboration
Certification
- Certified Six Sigma Professional
- Project Management
- Lean Management
- Culture of Kaizen
Publications
- Co-authored multiple peer-reviewed articles in international journals on pharmacology, salivary biomarkers, CNS studies, and herbal medicine.
- "Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective," published in the December issue of the European Medical Writers Association (EMWA) Journal.
Accomplishments
- Co-authored multiple peer-reviewed articles in international journals on pharmacology, salivary biomarkers, CNS studies, and herbal medicine.
'Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective,' published in the December issue of the European Medical Writers Association (EMWA) Journal. - Recognized in Parexel's India Country Head Recognition Program for outstanding performance in individual category
Languages
Bengali
First Language
English
Proficient (C2)
C2
Timeline
Medical Writer II
Parexel International
01.2023 - Current
Medical Writer I
Parexel International
07.2021 - 02.2023
Senior Drug Safety Associate
Novo Nordisk Service Centre
01.2021 - 06.2021
Disclosure Medical Writer
Novo Nordisk Service Center
02.2020 - 12.2020
Drug Safety Associate II
Accenture Operations Pvt. Ltd
05.2018 - 02.2020
Medical Service Analyst
Accenture Operations Pvt. Ltd
07.2015 - 05.2018
M.Pharm - Pharmacology
Rajiv Gandhi University of Health Sciences
B.Pharm -
Rajiv Gandhi University of Health Sciences
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