Job Summary

We are looking for a Medical Writer I to support the preparation, review, and delivery of clinical and regulatory documents. The ideal candidate will have a strong scientific background, excellent writing skills, and an understanding of clinical research and drug development processes.

Key Responsibilities

- Author, edit, and review clinical and regulatory documents, including: Clinical Study Reports (CSRs), Interim Study Reports, Informed Consent Forms (ICFs), Safety Update Reports, Patient Narratives
- Conduct literature searches and scientific reviews to support document development.
- Analyze and interpret clinical study data to prepare high-quality scientific content.
- Ensure compliance with ICH-GCP guidelines, SOPs, templates, and regulatory requirements.
- Perform quality checks to ensure data accuracy, consistency, and document integrity.
- Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs.




- Support document review cycles, manage timelines, and address stakeholder feedback.

Skills

- Strong clinical and scientific writing skills.
- Good understanding of clinical research, drug development, and regulatory guidelines.
- Experience with medical writing, clinical documentation, or medical communications.
- Excellent written and verbal communication skills.
- Robust attention to detail and organizational skills.
- Proficiency in Microsoft Word, Excel, SharePoint, and document management systems.
- Ability to manage multiple projects and work effectively in a collaborative environment.

Qualifications

- Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related healthcare discipline.
- Experience within a CRO, pharmaceutical, biotechnology, healthcare, or medical communications organization preferred.

📌 Medical Writer I (Secunderabad)
🏢 Parexel
📍 Secunderabad