Parexel
10,000+ employees
Founded 1983
âïž Healthcare Insurance
𧏠Biotechnology
đ Pharmaceuticals
đ° Venture Round on 1990-01
Healthcare Insurance âą Biotechnology âą Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
Senior Medical Writer
đ„ 0 minutes ago
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Parexel
10,000+ employees
Founded 1983
âïž Healthcare Insurance
𧏠Biotechnology
đ Pharmaceuticals
đ° Venture Round on 1990-01
Healthcare Insurance âą Biotechnology âą Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
đ Description
âą 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. âą Conduct literature reviews and analyze scientific and clinical data to support document development. âą Ensure documents comply with ICH-GCP, FDA, EMA, client requirements, SOPs, and regulatory guidelines. âą Coordinate cross-functional reviews, manage document timelines, and incorporate stakeholder feedback. âą Serve as the Medical Writing representative on project teams and act as a primary point of contact for assigned projects. âą Review statistical outputs and ensure accurate presentation and interpretation of clinical data. âą Perform quality reviews to ensure data consistency, accuracy, and publishing readiness. âą Mentor junior writers and contribute to process improvement, training, and SOP development initiatives.
đŻ Requirements
âą Bachelor's, Master's, PharmD, MD, PhD, or equivalent degree in Life Sciences, Pharmacy, Medicine, or a related field. âą Must have experience in Medical Writing, preferably within a CRO, pharmaceutical, or biotechnology environment. âą Strong experience authoring clinical and regulatory documents such as Protocols, CSRs, Investigator Brochures, and CTD documents. âą Solid understanding of clinical research, drug development processes, and ICH-GCP guidelines. âą Excellent scientific writing, editing, and communication skills. âą Proficiency in Microsoft Word, Excel, document management systems, and collaborative authoring tools.
đïž Benefits
âą Health insurance âą Professional development opportunities
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