Sr Medical Writer
Share
Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Senior Medical Writer - Make an Impact at the Forefront of InnovationThe Senior Medical Writer provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients and demonstrates subject matter and therapeutic area expertise. The Senior Medical Writer may assist program manager. 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 research write or edit complex clinical and scientific and program level documents including IBs INDs and MAAs.
Review routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation the use of software for document development document types regulatory requirements and therapeutic area knowledge.
Ensure compliance with quality processes and requirements for assigned documents. Provide input on and independently develops best practices methods and techniques for achieving optimal results including various client specific processes.
May assist in program management activities. Identify and resolve out-of-scope activities. Duties could include developing timelines budgets forecasts and contract modifications.
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; Advanced degree preferred
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years).
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:
Excellent data interpretation and medical writing skills including grammatical editorial and proofreading skills
Strong project management skills
Excellent interpersonal skills including problem solving
Strong negotiation skills
Excellent oral and written communication skills with strong presentation skills
Significant knowledge of global regional national and other document development guidelines
In-depth knowledge in a specialty area such as preclinical therapeutic regulatory submissions communications etc.
Great judgment and decision-making skills
Excellent 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.
Required Experience:
Senior 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
