Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we're hoping you're here for the latter.
Who are we?
We Are PRA Bioanalytical Labs, with locations in Lenexa, KS USA and Assen, Netherlands, EU.
We are part of the 16,000+ employees strong for PRA Health Sciences, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
We are looking for an Analytical Writer to join our team who will be responsible for writing Bioanalytical and Method Validation Reports of clinical or non-clinical studies performed in the Bioanalytical Laboratories of PRA Health Sciences according to International guidelines, regulatory and Sponsor requirements. The Analytical Writer assists with related tasks as necessary for timely completion of studies. Formatting/revision of other non-report documents is also part of the responsibility.
What will you be doing?
- Write Bioanalytical and Method Validation Reports per PRA or Sponsor template through assembly of data from various sources
- Communicate with responsible Project Manager and Operational Team Leader about lab study results and conclusions to be reported
- Review the reports written by colleagues
- Process the review comments from internal and Sponsor reviewers to draft/final reports
- Finalize reports according to eCTD (pdf) requirements
- Coordinate final report sign-off and approval
- Track report milestones to complete assigned tasks on-time
- Join Pre/ Post-study Project Team Meetings
- Track and manage shipments of hard-copy reports
What do you need to have?
- Basic Microsoft Word user
- Read, write and speak fluent English; fluent in host country language required
- Laboratory education or experience at High School diploma level
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.