Associate 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 Compilation Specialist - Make an Impact at the Forefront of Innovation
The Compilation Specialist provides complex study reporting and other project services to department personnel. Compiles coordinates revises and finalizes appendix documents. The role involves interaction with project teams within the company and in many cases direct contact with clients to ensure that all federally required documents are complete accurate and final according to local national or international regulatory authorities. The Compilation Specialist enforces timelines and ensures deliverables are met for project teams and in some cases for the client.
What Youll Do:
Provide study reporting and project services to the team.
Compile organize and publish clinical study reports including appendices.
Support document formatting and report publishing.
Evaluate the compilation needs in relationship to the overall project timelines quality & delivery.
Engage other project team members functional units or management as necessary to deliver final product and resolve/mitigate identified issues or barriers to delivery.
Maintain high level of expertise providing accurate and complete documents to ensure that materials sent to clients are of high quality and without error.
Assume leadership for complex compilation projects as necessary; provide training and guidance to junior team members.
Education & Experience Requirements:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to at least 4 years).
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills Abilities:
Good understanding of FDA and ICH guidelines
Strong understanding of clinical research and/or regulatory environment
Capable of balancing client standards and company procedures with regulatory requirements
Strong grammatical and communication skills both written and oral including English grammar
Strong software skills including but not limited to Microsoft Word Excel and Adobe Acrobat
Solid problem-solving capabilities and organizational skills
Capable of independently performing numerous tasks simultaneously without losing sight of overall objectives
Adaptable to changes in work duties responsibilities and requirements
Capable of working independently as well as part of a team
Strong editorial and proofreading skills
Thorough knowledge of medical terminology
Familiarity with regulatory documents.
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations. Potential Occasional travel required.
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:
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
