job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!
location: North Chicago, Illinois
job type: Contract
salary: $39.00 - 42.11 per hour
work hours: 8 to 4
- Describe the primary goals, objectives or functions or outputs of this position.
- Assists the Clinical Trial Disclosure (CTD) area with the execution of Company clinical drug trial registration (primarily) and results disclosure postings per the applicable regulatory and Standard Operating Procedure (SOP) requirements.
- Works closely with/supports the Senior Associate, CTD and Manager(s) of CTD: to determine the Company drug trials required to be registered and results disclosed, to effectively communicate this information and related timelines to the applicable individuals involved in these activities, to provide guidance to and build cross-functional collaborative relationships, to coordinate the completion of these activities to achieve/ensure timely disclosure of accurate and complete information.
- Works closely with/support the Senior Associate, CTD and Manager(s) of CTD in operationalizing changes in both the US and International regulatory environment via participation in the development and implementation of SOPs/processes as well as creates efficiency improvements/furthers system automation and related communication and training activities.
- Participates in CTD compliance prevention by providing QC checks and metrics as requested.
- Maintains/tracks CTD for Company clinical drug trials, including the documentation and storage of the information.
- Cross-trains with other CTD staff.
- Accountable for meeting the main objectives of assigned projects/roles and responsibilities within established timelines and with an appropriate quality level.
- Accountable to Senior Manager, CTD. Act as a key contributor, who exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
- Daily interaction with Senior Associate, CTD and/or Manager(s) of CTD as well as significant interface/communication with cross-functional areas.
- Expedient escalation of issues to management is essential and may have a direct impact on CTD compliance.
- Bachelor's degree (BA/BS) from an accredited college or university is required, preferably in a health or biological science field.
- Must have 2+ years of clinical research experience or experience in a related area such as quality or regulatory and working knowledge of drug development.
- Must be familiar with ICH and GCP Guidelines and have good organizational and communication skills and competent in application of standard business procedures (SOPs/Work Instructions, OEC).
- Must have the ability to prioritize roles and responsibilities daily and work well under deadline pressure in a team environment in order to execute goals to ensure they are achieved (i.e. maximizes individual skills utilizing the collective skills of the CTD area).
skills: SOP, FDA, CTD Structure, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.