Principal Medical Writer
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Job Location:
Monthly Salary:
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Principal Medical Writing - Make an Impact at the Forefront of InnovationAs a Principal Medical Writer you will serve as the primary author by writing and providing input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
What Youll Do:
Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
As the lead writer review documents for the team and provide training and guidance to junior team members.
Provide advice on document development strategy regulations and industry best practices.
Demonstrate subject matter and therapeutic area expertise.
Act as backup program manager.
Collaborate with internal and external clients supporting and enabling effective and efficient communication that results in operational excellence.
Education & Experience Requirements:
Bachelors degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
Experience within regulatory medical writing (comparable to 8 years) required
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) 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:
Significant knowledge of global regional national and other document development guidelines
In-depth knowledge in one or more specialty areas such as preclinical therapeutic regulatory submissions communications etc.
Excellent data interpretation and medical writing skills including grammatical editorial and proofreading skills
Excellent project management skills
Advanced interpersonal oral and written communication and presentation skills
Excellent negotiation skills
Excellent judgment; high degree of independence in decision making and problem solving
Ability to mentor and lead junior level staff.
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.
Required Experience:
Staff IC
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
