ICON Clinical Research Senior Technical Writer in North Wales, Pennsylvania

Senior Technical Writer

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. This person is responsible for documentation associated with the specifications, development and use of software system .

  • Overview of the Role*

  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

  • Travel (approximately 5%) domestic and/or international.

  • Document and review user requirements*

  • Derive functional requirements from user requirements and interface with developers to create software requirements specifications and design specifications*

  • Document version control*

  • Create other documentation associated with the SDLC including validation packages, system executive summaries and system user manuals.*

  • Other duties as assigned

  • Role Requirements*

  • To perform this job successfully , an individual must be able to perform each essential duty

  • satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability

  • required. Reasonable accommodations may be made to enable individuals with disabilities to perform

  • the essential functions.

  • US/LATAM/CAN: a minimum 5 years technical writing experience

  • EU/APAC: In depth proven technical writing experience

  • Proficient with W2000/XP+ operating system

  • Proficient with MS Office 2000+/XP business applications

  • Working knowledge of 21 CFR Part 11

  • Working knowledge of the software development life cycle

  • Trained in GCP

  • Trained in computerized systems in clinical trials

  • Organizational skills

  • Highly effective communication skills

  • Highly proficient documentation skills

  • Bachelors degree, local equivalent or relevant work history

  • Benefits of Working in ICON*

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

  • What’s Next?*

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

  • ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.*