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AI Summary
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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.
Good 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.
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