Informed Consent Writer
- United States
- Medical Writing
- ICON Strategic Solutions
- Remote
TA Business Specialist
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
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 Informed Consent Writer (ICW) is responsible for preparing informed consent documents that disclose information about a clinical trial using health literate language to help a candidate make an informed decision about trial participation. The ICW will work across multiple therapeutic areas using tools, systems, guidelines, templates, and processes. The ICW is to demonstrate the following skills:
Responsibilities
- Read and understand protocol-specific design, objectives, and study procedures
- Prepare study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries (when appropriate), and required risk language
- Work with protocol authors to ensure comprehensive understanding of protocol details and the protocol approval timeline
- Write, edit and review informed consent documents that reflect the principles of health literacy
- Manage informed consent writing projects including the design, planning, and preparation of documentation in support of clinical development
- Participate, when appropriate, in clinical trial team meetings to ensure timely delivery of the informed consent document(s)
- Resolve document issues relating to informed consent
- Support Global Clinical Trial Operations with informed consent process expertise and study specific support
- Possible participation in the orientation and coaching of junior team members
- Possible participation in initiatives to improve medical writing processes and standards
- Support tool development, enhancements, and testing, as applicable
- Ensure compliance with company training and time reporting
Scientific Knowledge/Health Literacy
- Understanding of protocol structure and knowledge of the relevant information needed to create an informed consent document
- Understanding of clinical trial operations with specific knowledge of informed consent forms
- Ability to prepare, with minimal supervision, a summary of a clinical trial design, objectives and activities for a lay audience using established guidelines and governmental regulations in a clear, concise and health-literate format
- Understanding of appropriate International Council on Harmonisation (ICH) and regulatory guidance pertaining to Informed Consent
Technology Skills
- Technical expertise in MS Office (Word, Excel, Project) and Adobe Acrobat
- Experience working in document management systems; managing workflows
- Experience with collaborative authoring and review tool
- Understanding of structured content management concepts
- Flexibility in adapting to new tools and technology
Other
- Ability to work in a deadline-driven environment, and ability to work both independently and collaboratively with teams
- Complete fluency in reading and writing American English
- Excellent communication skills (email responses, meeting presentations)
- Effective time management, organizational, and interpersonal skills
- Customer focus
- Strong project management skills
- Life sciences degree
- 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Career ProgressionContent type
BlogsPublish date
07/20/2023
Summary
Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic
Teaser label
Our PeopleContent type
BlogsPublish date
02/28/2023
Summary
John Bailey, one of ICON's Veteran Leadership Transition Program Alumni shares his path from serving in the armed forces to joining the clinical research industry. ICON's Veteran Leadership Transit
by
John Bailey
Teaser label
Career ProgressionContent type
BlogsPublish date
12/21/2022
Summary
Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune
by
Jamie Kempski
Who we are
Similar jobs at ICON
Salary
Location
Belgium, United Kingdom, Denmark, France, Spain, Germany, Netherlands, Switzerland
Department
Medical Affiars & Medical Writing Roles
Location
Belgium
Denmark
France
Germany
Netherlands
Spain
Switzerland
UK
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. As principal medical writer, you will be
Reference
2023-103952
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
Poland
Department
Medical Affiars & Medical Writing Roles
Location
Poland
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
Senior Clinical Trial Transparency Associate is responsible for CTT deliverables, the role is single sponsor dedicated. The role can be based in Eastern Europe
Reference
2024-110086
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
India, Chennai
Location
Chennai
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Medical Writing
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR118768
Expiry date
01/01/0001
Author
Puja JaiswalAuthor
Puja JaiswalSalary
Location
Germany, Europe, United Kingdom, Switzerland
Department
Medical Affiars & Medical Writing Roles
Location
Any EMEA Location
Germany
Switzerland
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
Senior Clinical Trial Transparency Associate is in charge of preparing scientific content to be posted on intranet websites (Health Authority, Company) based on source documents, according to defined
Reference
2024-109700
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
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-110004
Expiry date
01/01/0001
Author
Brendan HoeyAuthor
Brendan HoeySalary
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 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 suppo
Reference
2024-109841
Expiry date
01/01/0001
Author
Brendan HoeyAuthor
Brendan Hoey