Analytical Writer - Bioanalytical Lab Early Development

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:

• Complete understanding and application of ICON’s writing process

• 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

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.