Remote Medical Writer Jobs at Parexel, India | Pharmacovigilance Job Opportunity!
Parexel is a global biopharmaceutical services organization specializing in comprehensive drug development and regulatory consulting. With a commitment to advancing healthcare, Parexel operates across various therapeutic areas to ensure the safety and efficacy of medical products. The company is headquartered in the United States and maintains a significant presence in India, including Hyderabad and Bengaluru, focusing on innovative solutions in medical affairs and pharmacovigilance.
About the role
The Medical Writer I position in Patient Safety involves critical responsibilities contributing to the safety and efficacy of medical products. This remote role in India focuses on preparing and compiling safety reports, conducting safety analyses, managing client communications, engaging in signal detection activities, and assisting in preparing Risk Management Plans.
Responsibilities
- Author and review clinical and regulatory documents, including Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports.
- Conduct literature reviews and analyze scientific and clinical data to support document development.
- Ensure documents comply with ICH-GCP, FDA, EMA, client requirements, SOPs, and regulatory guidelines.
- Coordinate cross-functional reviews, manage document timelines, and incorporate stakeholder feedback.
- Serve as the Medical Writing representative on project teams and act as the primary point of contact for assigned projects.
- Review statistical outputs and ensure accurate presentation and interpretation of clinical data.
- Perform quality reviews to ensure data consistency, accuracy, and publishing readiness.
- Mentor junior writers and contribute to process improvement, training, and SOP development initiatives.
Requirements
- Bachelor’s, Master’s, PharmD, MD, PhD, or equivalent degree in Medicine or a related field.
- Experience in Medical Writing, preferably within a CRO, pharmaceutical, or biotechnology environment.
- Strong experience authoring clinical and regulatory documents such as Protocols, CSRs, Investigator Brochures, and CTD documents.
- Solid understanding of clinical research, drug development processes, and ICH-GCP guidelines.
- Excellent scientific writing, editing, and communication skills.
- Proficiency in Microsoft Word, Excel, document management systems, and collaborative authoring tools.
Job ID: R0000042163 | Location: India (Remote) | Category: Medical Affairs