Senior Medical Writer – FSP
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Job Description
Medical Writer producing clinical study reports, protocols, and regulatory documents for Thermo Fisher Scientific. Supporting pharmaceutical/CRO projects through scientific writing, quality compliance, and program coordination.
Responsibilities:
- Serve as primary author for routine documents such as clinical study reports and study protocols, and summarize clinical study data
- 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
- Represent the department at project launch, review, and project team meetings
- Collaborate with internal and external clients to support effective communication and operational excellence
Requirements:
- Bachelor's degree in a scientific discipline or equivalent relevant formal academic/vocational qualification
- 2+ years of comparable relevant experience
- Experience in the pharmaceutical/CRO industry preferred
- Experience in scientific writing advantageous
- Solid medical writing, grammatical, editorial, and proofreading skills
- Ability to interpret and present complex data accurately and concisely
- Effective administrative, organizational, and planning skills with attention to detail and quality
- Ability to work independently and effectively within a team
- Effective oral and written communication skills
- Knowledge of regulatory documentation and the drug development process
- Judgment and decision-making skills
- Good computer skills and proficiency with client templates
- Knowledge of document management systems and relevant applications such as Excel and Outlook
- Occasional willingness to drive to site locations and travel domestically and internationally
Benefits:
- Collaboration and development as part of the everyday experience
- Reasonable accommodation for individuals with disabilities during application, interview, and employment
- Equal opportunity employment
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