Compliance Specialist I

“At ICON, it's our People that set us Apart”

Are you passionate about improving the quality of human life? If so, we invite you to join us in creating a healthier world tomorrow.

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.

We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.

Job Title                                 : Compliance Specialist I

Reporting to                          : Manager

Type of Employment           : Full Time

Location                                 : India, Chennai

No of yrs. of exp                   : 1 to 2 + years of relevant experience with the ability to write accurate and

efficient SQL queries    with level ranging from low to medium complexity.

Ensure quality compliance is maintained within the Interactive Technologies division during the project development and maintenance phase.

Key Responsibilities & Duties:

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.*
• Travel (approximately 0%) domestic and/or international
• Perform Quality Management Reviews (QMRs) of low to medium complexity on active projects as assigned*
• Ensure projects adhere to the System Development Life Cycle (SDLC) and/or applicable processes*
• Identify gaps and inconsistencies in data and make rational judgements from available information and analysis*
• Communicate with department management and project regarding quality and/or compliance issues and trends*
• Make independent judgments as the subject matter expert in order to complete compliance specialized tasks/requests*
• Provide critical input for proactive resolutions and improvements related to role*
• Communicate with internal and external clients on compliance related matters*
• Maintain confidentiality of project information as appropriate*
• Train and mentor team members as assigned
• Other responsibilities may be assigned as required

Experience required

• 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.
• Ability to perform all assigned tasks with moderate supervision and review
• Ability to manage multiple tasks and timelines with moderate supervision
• Ability to liaise professionally with internal and external clients
• Ability to work in a team environment and resolve conflict
• Knowledge of clinical trials is preferred
• Possess strong verbal and written communication skills
• Ability to write accurate and efficient SQL queries with level ranging from low to medium complexity
• EU/APAC - prior relevant experience in a quality compliance or quality assurance role preferred.  Alternatively prior experience in clinical research
• US/LATAM/CAN - Minimum of 1+ year of quality compliance or quality assurance experience preferred. Alternatively 1 year prior experience in clinical research                                                                                                                                                                                                                        

• Bachelor’s degree or local equivalent preferred.
• An alternative combination of experience, education and training determined by management to be equivalent to the foregoing

Benefit Working with ICON:

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, and life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. 

When you spot an opportunity you’re interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.

The evaluation will look at your technical skills and your competencies – for example, delivering excellence.

After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.

If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.