Analytical Writer (Lenexa, KS)
- Lenexa
- Medical Writing
- ICON Full Service & Corporate Support
- Office Based
About the role
This vacancy has now expired. Please click here to view live vacancies.
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Role:
Responsible for writing Bioanalytical and Method Validation Reports of clinical or non-clinical studies performed in the Bioanalytical Laboratories of ICON plc 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.
Responsibilities:
Report Writing:
Write Bioanalytical and Method Validation Reports per ICON 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.
Document Control:
Create and modify templates as needed.
Support development of lab result sheets, laboratory notebooks and Assay Instructions.
Create and modify Analytical Writing SOPs and Work Instructions as needed.
Assist the Project Manager as required by writing Study Plans, Notes-to File, Deviations etc.
Assign and maintain Assay Instructions.
Review Study file for completeness and archive at completion of study.
Assign and maintain records for laboratory notebooks.
Track and maintain records for sample preparation and instrument templates.
Qualifications:
Basic application of Microsoft Word and Excel (Advanced preferred)
Laboratory education or experience at University of Applied Sciences level
Read, write and speak fluent English
Previous work experience in laboratory or scientific environment preferred
Bachelor degree preferred (ideally in one of the Sciences)
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
#LI-DL1
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
Similar jobs at ICON
Salary
Location
Romania, Bucharest
Location
Bucharest
Business Area
ICON Full Service & Corporate Support
Job Categories
Medical Writing
Job Type
Permanent
Description
We are currently seeking a Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medi
Reference
JR129492
Expiry date
01/01/0001
Author
Sophia CairnsAuthor
Sophia CairnsSalary
Location
Ireland, Dublin
Department
Full Service - Development & Commercialisation Solutions
Location
Dublin
Business Area
ICON Full Service & Corporate Support
Job Categories
Medical Writing
Job Type
Permanent
Description
We are currently seeking a Medical and Scientific Writer II to join our diverse and dynamic team. As a Medical and Scientific Writer II at ICON, you will play a pivotal role in the development and pre
Reference
JR129679
Expiry date
01/01/0001
Author
Sophia CairnsAuthor
Sophia CairnsSalary
Location
Switzerland
Department
Medical Affiars & Medical Writing Roles
Location
Switzerland
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Principal Medical Writer I is responsible for the devel
Reference
2025-119106
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
United States
Department
Medical Affiars & Medical Writing Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-119193
Expiry date
01/01/0001
Author
Brendan HoeyAuthor
Brendan HoeySalary
Location
United Kingdom, Europe
Department
Medical Affiars & Medical Writing Roles
Location
Any EMEA Location
UK
Remote Working
Remote
Area of interest
Europe ICON Full Service & Corporate Support Talent Acquisition
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Senior Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As a Senior Medical Writer you will be fully
Reference
2025-119206
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
United Kingdom, Ireland, Germany
Department
Medical Affiars & Medical Writing Roles
Location
Germany
Ireland
UK
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
Senior Medical Writer position, Maidenhead (Eng), Galway (Ireland) or Jena (Germany) – In Vitro Diagnostics/Medical Devices You will be partnering with a well-known leader in in vitro diagnostics, wh
Reference
2025-117999
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia Roth