Job Title: Medical Writer I
Job Location: India - Asia Pacific - Home-Based
Company Overview
Syneos Health is a leading biopharmaceutical solutions organization that integrates clinical, medical affairs, and commercial insights to accelerate customer success. The company brings patients and customers to the center of its operations, driving innovation and efficiency in the delivery of therapies.
Role Summary
As a Medical Writer I, you will support the preparation and editing of a variety of clinical and medical documents. You will work with moderate supervision, contributing to documents such as clinical study protocols, reports, patient narratives, and investigator brochures. You will also be involved in reviewing statistical plans and ensuring regulatory compliance throughout the writing process.
Key Responsibilities
Compile, write, and edit medical writing deliverables with moderate supervision.
Develop or support the creation of documents, including but not limited to:
Clinical study protocols and protocol amendments
Clinical study reports
Patient narratives
Investigator brochures
Review statistical analysis plans, tables, figures, and listings for content, grammar, format, and consistency.
Interact with staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
Adhere to regulatory standards such as ICH-E3 guidelines and company-approved templates for document completion.
Conduct online clinical literature searches as applicable.
Continue professional development to stay updated on regulatory guidance and improve writing skills.
Manage project budgets and timelines, ensuring work is completed on time and within the allocated budget.
Complete administrative tasks within specified timeframes.
Perform additional duties as assigned, with minimal travel (less than 25%).
Qualifications
Required
Education: A postgraduate degree in Life Sciences, preferably M.Pharm or PharmD.
Experience:
Experience in Clinical Trial Disclosure, Regulatory Medical Writing, and Pharmacovigilance (Safety Narrative Writing).
Experience drafting CTD documents and performing quality checks (QC) for client documents.
Familiarity with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), and EUCTR.
Desirable
Ability to work independently and within a team to meet deadlines.
Strong attention to detail and adherence to regulatory guidelines.
Work Environment
Syneos Health is dedicated to developing its employees through career progression, technical training, peer recognition, and a robust total rewards program. The company promotes a Total Self culture, ensuring everyone can authentically be themselves at work.
How to Apply
Interested candidates can apply through the Syneos Health career portal.
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