Posting ID: JP-002053466
Will work closely with Clinical Affairs department to write and edit documentation to support IVDR submissions. Duties may also include performing literature searches
4 Open Positions:
3 positions will be within R&D also supporting IVDR compliance
1 position will support clinical operations with IVDR
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Draft clinical trial documents to support IVDR Submissions
- Perform literature searches, as needed
ADDITIONAL RESPONSIBILITIES and REQUIREMENTS
Note: The list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities that management may deem necessary from time to time.
- Ensure consistency, completeness, accuracy and conformance to client's style guidelines
- Exhibit strong initiative and is willing to accept challenging projects
- Ability to handle multiple projects and work well under pressure
- Experience in writing protocols and summary reports to support regulatory submissions
Main daily responsibilities of the worker: this particular team is involved with pre-clinical studies; review legacy documentation; determine what documents can be used for IVDR submission; look for gaps and prepare protocols for new study and data
The R&D Technical Writer is responsible for preparing documentation for client's products for the purpose of IVDR compliance. Work closely with development and support organizations to write and edit documentation for client's products. Write plans and reports that explain scientific and technical information in simple language.
- Review current product data and reports to create document deliverables for IVDR remediation.
- Develop a basic level of understanding of the company’s products, applications and markets. Understand basic system functionality and operation of client's instrumentation.
- Ability to recognize gaps in data and develop strategies to fulfill the regulatory requirement.
- Write the documentation according to the audience (e.g. FDA, Medical Technology, etc.) and technical content defined in the documentation plan.
- Work with project managers and subject matter experts to determine documentation requirements.
- Ensure consistency, completeness, accuracy, and conformance to client's style guidelines.
- Maintain records and files of work and revisions according to client's procedures and processes.
- Proficient with Microsoft Word and SharePoint
- Exhibit strong initiative and is willing to accept challenging projects.
- Utilize existing documentation as a reference for enhancement and development of new documents.
Writing clear, concise and informative documentation.
Top Skills Details:
Clinical Study/clinical trials
Additional Skills & Qualifications:
Technical/software: proficiency with MS Word; SharePoint
Soft skills: self-motivated; ability to take on task and independently find solutions based on the deliverable required; good communicator
Industry/companies preference: healthcare and medical device preferred; FDA-regulated
Education: Bachelor’s degree (will consider Associate’s degree with relevant work experience)
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Tae Yi