Alekya Vemula
Hyderabad
Summary
Accomplished Senior Associate Regulatory Writer with a proven track record in regulatory medical writing and project management. Excelled in authoring CSRs and leading cross-functional teams, ensuring project completion on time. Skilled in ICH-GCP guidelines and SOP development, with a flair for training and mentoring, significantly enhancing team capabilities.
Overview
8
8
years of professional experience
Work History
Senior Associate Regulatory Writer
Novartis Healthcare Pvt Ltd
Hyderabad (Hybrid)
05.2023 - Current
- I am currently working on authoring various documents, such as CSRs, eNarratives, and reviewing SAPs and TFLs.
- Coordinated cross-functional teams in completing projects on time.
- Led meetings with clients to discuss project objectives, timelines, and deliverables.
Lead Medical Writer
IDD Research Solutions
Chennai (Remote)
05.2022 - 03.2023
- Served as the lead medical writer, authoring protocols, informed consent forms (ICFs), case report forms (CRFs), and standard operating procedures (SOPs), while managing the medical writing department.
Medical Writer
IDD Research Solutions
Chennai (Remote)
06.2021 - 04.2022
- I worked as a junior medical writer, where I was responsible for drafting protocols, informed consent forms (ICFs), and case report forms (CRFs).
Clinical Research Associate
Innvocept Global Solution
Hyderabad (Hybrid)
04.2020 - 01.2021
- I reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practice guidelines. I coordinated the submission of regulatory documents to Institutional Review Boards (IRBs), Ethics Committees (ECs), and other relevant authorities. Additionally, I conducted site initiation visits and monitored ongoing studies at investigator sites.
- I interacted with sponsors, Contract Research Organizations (CROs), investigators, vendors, and subcontractors as needed. I also prepared reports summarizing study progress and results for senior management review. Furthermore, I ensured the timely completion of all deliverables by tracking project timelines and milestones.
Research Monitor
St Johns Research Institute
Bangalore (On-site)
06.2019 - 08.2019
- Worked as an in-house research monitor.
- Managed the daily operations, like conducting meetings with senior management, and discussing updates on current projects.
Clinical Research Coordinator
St Johns Research Institute
Bangalore (On-site)
12.2016 - 05.2019
- I worked as a Clinical Research Coordinator, managing clinical trial projects in the Department of Medicine.
- My duties included compiling trial documents for regulatory submissions, assisting with Institutional Review Board (IRB) preparations, and monitoring patient safety according to established guidelines, accurate tracking logs for clinical research activities, including adverse events, and lab results.
- Additionally, I collected and processed specimens from participants, and conducted screening interviews to determine subject eligibility.
- I coordinated investigator meetings and maintained communication with all stakeholders throughout the trial lifecycle.
Education
Post-graduation Diploma - Clinical Research
Mysore University
Bangalore06-2018
Pharm D - Clinical Pharmacy
Osmania University
Hyderabad01-2016
Skills
- Regulatory medical writing
- CTD modules
- ICH-GCP Guidelines
- Protocol
- CSR
- ICF
- CRF
- Manuscript
- Quality Assurance
- SOP
- Timeline estimates
- DCGI SEC Presentations
- Project coordination
- Project management
- Training and mentoring
Affiliations
ISCR - Lifetime Membership
Accomplishments
- 10/22, IDD Research Solutions - Spot Award for Oct 2022
- 05/22, Promoted to Lead Medical Writer within 1 year of working as a Medical Writer
- 08/21, IDD Research Solutions - Spot Award for Aug 2021
- 03/19, Travel grant for Investigator meeting, Singapore by Newron Pharmaceuticals
- 02/19, Travel grant for Global Hemophilia Network training program, Thailand by Novo Nordisk
- 12/18, Training grant for One-week international course in Health Research Methodology & Evidence-Based Medicine, Bangalore by St. John’s Research Institute
- 09/18, Travel grant and training grant for Hematopoietic stem cell transplantation (HSCT) Data management training, at CMC Vellore supported by St. John’s Research Institute
- 05/18, Travel grant for Investigator meeting, Malaysia by PPD/ Alnylam Pharma
- 02/18, Travel grant for Investigator meeting, Delhi by Novo Nordisk
- 2018, St. John’s Research Institute – Achieved Global first subject enrollment and first PK subject enrollment for Candia Auris, phase II study as a CRC.
- 2018, St. John’s Research Institute - Achieved Global highest recruitment for Afibrinogenemia, phase I/II study in adolescents and adult population as a CRC.
- 2017, St. John’s Research Institute - Global highest recruitment for Afibrinogenemia, phase III study in the pediatric population as a CRC.
- 2017, St. John’s Research Institute - Global highest recruitment for Afibrinogenemia, phase III study in the adult population as a CRC.
Total project experience
As a Medical Writer – Authored & reviewed Protocols, ICFs, Case Report Forms, Clinical Study Reports, and manuscripts; conducted internal study training; and presented the studies in DCGI SEC meetings.
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Advanced (C1)
C1
References
References available upon request.
Timeline
Senior Associate Regulatory Writer
Novartis Healthcare Pvt Ltd
05.2023 - Current
Lead Medical Writer
IDD Research Solutions
05.2022 - 03.2023
Medical Writer
IDD Research Solutions
06.2021 - 04.2022
Clinical Research Associate
Innvocept Global Solution
04.2020 - 01.2021
Research Monitor
St Johns Research Institute
06.2019 - 08.2019
Clinical Research Coordinator
St Johns Research Institute
12.2016 - 05.2019
Post-graduation Diploma - Clinical Research
Mysore University
Pharm D - Clinical Pharmacy
Osmania University
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