
Senior Medical Writer – FSP
Posted Aug 8

Posted Aug 8
This is a fully remote position, open to applicants in Chile.
• Act as the main author for routine documents, including clinical study reports and study protocols, while summarizing clinical study data.
• Support the creation of complex clinical, scientific, and program-level documents, such as Investigator’s Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs).
• Ensure that all assigned documents comply with quality processes and requirements.
• Contribute to identifying best practices, methodologies, and techniques for achieving optimal results.
• Assist in program management tasks, including the development of timelines, budgets, and forecasts.
• Represent the department in project launch, review, and project team meetings.
• Collaborate with both internal and external clients to enhance effective communication and operational excellence.
• A Bachelor's degree in a scientific field or an equivalent relevant academic/vocational qualification.
• A minimum of 2 years of relevant experience.
• Preferred experience in the pharmaceutical or Contract Research Organization (CRO) industry.
• Prior experience in scientific writing is advantageous.
• Strong medical writing, grammatical, editorial, and proofreading abilities.
• Capability to interpret and present complex data with accuracy and clarity.
• Strong administrative, organizational, and planning skills with a keen eye for detail and quality.
• Ability to work independently while also being effective in a team environment.
• Proficient oral and written communication skills.
• Familiarity with regulatory documentation and the drug development process.
• Strong judgment and decision-making capabilities.
• Good computer skills, including proficiency with client templates.
• Knowledge of document management systems and relevant applications such as Excel and Outlook.
• Willingness to occasionally travel to site locations domestically and internationally.
• Opportunities for collaboration and professional development as an integral part of the work experience.
• Reasonable accommodations for individuals with disabilities during the application, interview, and employment processes.
• Commitment to equal opportunity employment.
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