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.

- Valuable understanding of clinical research, drug development, and regulatory guidelines.

- Experience with medical writing, clinical documentation, or medical communications.

- Excellent written and verbal communication skills.

- Strong 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 (Serilingampalle (M))
🏢 Parexel
📍 Serilingampalle (M)