We are seeking a Medical Writer with extensive experience writing Clinical Study Reports for In Vitro Diagnostics (IVD). This is a fully remote 40-hour per week, contract opportunity that will last through the end of 2025.
location: Durham, North Carolina
job type: Contract
salary: $90 - 110 per hour
work hours: 9 to 5
education: Masters
responsibilities:
- Will be tasked with delivering Clinical Study Reports (CSR) for 2 IVD studies
- Will collaborate with members of cross-functional teams to prepare high-quality regulatory documents and clinical study-related documentsTracks progress on projects and provides regular updates to project lead and cross-functional teams through written and verbal communication (including team meetings)
- Will perform hands-on writing work, but will also make sure everyone is accountable for their part in the deliverable, setting up necessary meetings and owning the review process
qualifications:
Required:
- Bachelor degree or equivalent in medical-related or life science field
- At least 3 years of medical writing experience, preferably for in vitro diagnostics (IVD); pharmaceutical, biologics or medical device experience also acceptable.
- Proficient with Zotero reference management software
- Advanced Degree
skills: CSR, GCP (Good Clinical Practice), CTD Structure, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
