Senior Medical Writer – FSP

• Serve as primary author for routine documents such as clinical study reports and study protocols
• Summarize data from clinical studies
• Assist with complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs
• Ensure compliance with quality processes and requirements for assigned documents
• Assist in determining best practices, methods, and techniques for optimal results
• Assist with program management activities, including developing timelines, budgets, and forecasts for assigned deliverables
• Represent the department at project launch meetings, review meetings, and project team meetings
• Collaborate with internal and external clients to support effective communication and operational excellence

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
• 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• Experience working in the pharmaceutical/CRO industry preferred
• Experience in scientific writing advantageous
• Solid medical writing skills, including grammatical, editorial, and proofreading skills
• Ability to interpret and present complex data accurately and concisely
• Effective administrative, organizational and planning skills; attention to detail and quality
• Ability to work on own initiative and effectively within a team
• Effective oral and written communication skills
• Good knowledge of regulatory documentation and drug development process
• Great judgment and decision-making skills
• Good computer skills and proficiency with client templates
• Good knowledge of document management systems and relevant applications such as Excel and Outlook

• Collaboration and development opportunities
• Occasional domestic and international travel