About the role
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.
As a Technical Writer on the Quality, Compliance and Systems team within R&D Quality, this position is responsible for partnering with document, content, or process owners to provide controlled document authorship (SOPs, TOOLs, FORMs) within the R&D organization.
Essential functions include:
• Responsible for writing activities of SOPs, TOOLs, FORMs
• Collaborate with team members, subject matter experts, and reviewers to meet deadlines and produce high quality work products in accordance with stakeholder requirements.
• Provide overall level of consistency to controlled documents
• Drive clear, concise and consistent/harmonized controlled documents
• Improve and/or provide consistent formatting
• Assist with document management system (DMS workflow) requirements, including additional review of both content and format
• Ensure consistency in metadata in computerized system (DMS) for all documents
• Adhere to established regulatory standards and company-approved templates
• Subject matter expert for good documentation practices and overall technical writing requirements
- BS/BA degree required
- Minimum of 3 years of experience in writing regulated/controlled documents for pharmaceutical, biologic, or medical device companies.
- Ability to write & understand moderate to highly complex documents with technical proficiency
- Ability to work on multiple documents with multiple SMEs and prioritize work based on business needs to meet deadlines
- Ability to take existing and potential content and improve it
- Ability to convert complex documentation to easy language for multiple audiences
- Design software (such as content management system)graphical and DMS experience
- Strong computer skills, including MS Office software and experience with other innovative collaboration tools and technology
- Must be able to effectively work in a collaborative team
- Excellent written and verbal communication skills and fluency in written and spoken English
- Excellent time management skills and strong attention to
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.