Senior Medical Writer - Remote Position at Parexel, India

About Parexel

Parexel is a prominent global Clinical Research Organisation committed to enhancing patient care by assisting pharmaceutical, biotechnology, and medical device companies throughout the drug development process. The company is recognized for supporting innovative clinical research projects, providing high-quality scientific and regulatory documentation while fostering professional growth.

Job Overview

The Senior Medical Writer role at Parexel offers a full-time remote opportunity based in India. This position involves creating and reviewing clinical and regulatory documents crucial to global drug development programs. The role requires collaboration with cross-functional teams and mentoring junior writers to support research initiatives effectively.

Key Responsibilities

• Compose and critically assess documents such as Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports.
• Conduct comprehensive literature reviews and perform scientific and clinical data analysis.
• Ensure all documentation adheres strictly to guidelines including ICH-GCP, FDA, EMA, SOPs, and other regulatory standards.
• Manage document review processes and oversee adherence to project timelines.
• Act as the medical writing liaison for assigned projects, offering expert insight.
• Evaluate statistical data outputs to guarantee precise presentation of clinical findings.
• Perform quality assurance reviews to prepare documents for publication.
• Provide mentoring and guidance to junior medical writers to enhance team effectiveness.
• Participate in initiatives aimed at improving medical writing processes.
• Work collaboratively within global, cross-functional teams to meet project objectives.

Qualifications and Experience

• Possession of an MD degree is mandatory.
• Demonstrated experience in medical writing within clinical research organisations, pharmaceutical, or biotechnology firms.
• Strong background in clinical and regulatory documentation preferred.

Essential Skills

• Proficiency in medical, scientific, and regulatory writing.
• Expertise in developing clinical documentation such as CSRs, study protocols, and investigator brochures.
• Familiarity with ICH-GCP standards and FDA and EMA regulatory guidelines.
• Competency with Microsoft Word, Excel, and document management systems.