Remote Medical Writer Jobs at Parexel
Are you passionate about ensuring the safety and efficacy of medical products? At Parexel, a global leader in biopharmaceutical services, the role of a Medical Writer I in Patient Safety offers a unique opportunity to make a significant impact in the field of pharmacovigilance. The Remote Medical Writer Jobs in India involve preparing safety reports, conducting analyses, and managing client communications. With Parexel’s commitment to innovation and quality, candidates can contribute to advancing healthcare solutions.
About Parexel:
Parexel is a global biopharmaceutical services organization that specializes in providing comprehensive drug development and regulatory consulting services. With a commitment to advancing healthcare, Parexel operates in various therapeutic areas, ensuring the safety and efficacy of medical products. The company is headquartered in the United States and has a significant presence in India, including Hyderabad and Bengaluru, where it focuses on innovative solutions in medical affairs and pharmacovigilance.
Job Details:
- Designation: Medical Writer
- Primary Location: India
- Additional Locations: India, Remote
- Job ID: R0000042163
- Category: Medical Affairs
About this Role:
The Medical Writer I position in Patient Safety involves critical responsibilities that contribute to the safety and efficacy of medical products. The role entails preparing and compiling various safety reports, conducting safety analysis, and managing client communications effectively. The successful candidate will engage in signal detection activities and assist in preparing Risk Management Plans.
Key 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 a 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.
Eligibility Criteria for the Remote Medical Writer Jobs:
- Bachelor’s, Master’s, PharmD, MD, PhD, or equivalent degree in Medicine or a related field.
- Must have 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.
