Scientific & Regulatory Affairs · Bengaluru (on-site) · Reports to the Manager, Scientific & Regulatory Affairs
About the role
You will write and review the documents that run a clinical study. That means protocols, consent forms, study reports and papers. You will make sure each one is correct, clear and follows the rules.
If you have helped investigators turn a study idea into a protocol, or turned trial results into a paper, this job is for you.
What you will do
- Write and review study protocols, clinical study reports (CSRs), statistical analysis plans (SAPs), investigator brochures and informed consent documents.
- Write and review manuscripts, abstracts, posters and presentations.
- Prepare documents for ethics committees and regulators.
- Check that every document is scientifically correct and consistent with the protocol.
- Make sure documents follow ICH-GCP, CDSCO requirements,
the Current Drugs and Clinical Trials Rules 2019 and the Medical Devices Rules 2017.
- Handle several documents and deadlines at the same time.
- Able to travel for work about 10% of the time.
What you bring
- A Masters degree in Medicine or Dentistry
- 4–5 years of medical or scientific writing, including regulatory documents.
- A good grasp of clinical research, GCP, study design and basic statistics.
- Clear, careful writing. Good planning. Calm under deadlines.
Good to have
- Experience working with academic investigators or research institutions.
- Papers published in peer-reviewed journals.
How to apply
Apply on LinkedIn. Please attach one writing sample (a protocol section, report extract or published paper you wrote). Remove any confidential details.
📌 Medical Writer – Clinical Research (Bengaluru)
🏢 TrialGuna Private
📍 Bengaluru
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