FSP Medical Writer (Regulatory)
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Medical Writer - Make an Impact at the Forefront of Innovation
The Medical Writer provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. The role involves collaborating with internal and external clients supporting and enabling effective and efficient communication that results in operational excellence.
What Youll Do:
Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
May assist with more complex clinical and scientific and program level documents including IBs INDs and MAAs.
Ensure compliance with quality processes and requirements for assigned documents. May assist in determining best practices methods and techniques for achieving optimal results.
May assist in program management activities. Duties could include assisting with developing timelines budgets and forecasts for assigned deliverables.
Represent the department at project launch meetings review meetings and project team meetings.
Education & Experience Requirements:
Bachelors degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years).
Experience working in the pharmaceutical/CRO industry preferred
Experience in scientific writing advantageous
Years of experience refers to typical years of related experience needed to gain the required knowledge skills and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge Skills Abilities:
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 skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel Outlook)
Working Conditions and Environment:
Work is performed in an office environment.
Exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
Long varied hours required occasionally.
Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthroughs.
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
