Medical Writer I - Remote Position at Parexel

About Parexel

Parexel is a premier global Contract Research Organisation (CRO) committed to accelerating the creation of innovative therapies. Working with pharmaceutical, biotechnology, and healthcare clients worldwide, Parexel offers expertise in clinical research, regulatory consultancy, and medical writing services. The company is distinguished by its scientific rigor, commitment to quality, and innovation, providing employees the chance to contribute to transformative projects that positively affect patient health across the globe.

Role Overview

We are seeking a Medical Writer I to remotely support the creation of high-quality clinical and regulatory documentation. This full-time role based in India requires collaboration with cross-functional teams to produce content essential for global drug development initiatives. This position is perfect for candidates eager to build a career in medical writing within an esteemed clinical research environment.

Key Responsibilities

• Create, revise, and assess clinical and regulatory documents such as Clinical Study Reports (CSRs), Interim Study Reports, Informed Consent Forms (ICFs), Safety Update Reports, and Patient Narratives.
• Perform systematic literature searches and scientific evaluations to aid document preparation.
• Interpret clinical study data to compose precise scientific narratives.
• Ensure adherence to ICH-GCP standards, standard operating procedures, templates, and regulatory expectations.
• Conduct thorough quality assurance checks to maintain data integrity, accuracy, and consistency in documentation.
• Partner with teams from Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs departments.
• Facilitate document review processes, coordinate scheduling, and respond to stakeholder inputs effectively.

Eligibility Criteria

• Possession of a Bachelor's or Master's degree in Medicine or a related healthcare field.
• Preferably experienced within CROs, pharmaceutical, biotechnology, healthcare, or medical communications sectors.

Required Skills

• Proficient clinical and scientific writing capabilities.
• Sound understanding of clinical research methodologies, drug development processes, and regulatory frameworks.
• Experience with medical writing, clinical document authoring, or medical communication roles.
• Excellent command of both written and spoken communication.
• Strong attention to detail coupled with excellent organizational aptitude.
• Skilled in Microsoft Word, Excel, SharePoint, and document management platforms.
• Capable of managing concurrent projects and collaborating effectively within diverse teams.