Job Description

job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding 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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you\'re looking for a position where you can serve as an asset to your company while making a difference in others\' lives, we have the ideal position for you!

location: Lake Zurich, Illinois
job type: Contract
salary: $24.00 - 27.58 per hour
work hours: 9 to 5
education: High School

responsibilities:

• Submission publishing and compiling

• Adheres to established Quality/Regulatory Procedures demonstrating sound knowledge regarding technical and regulatory publishing skills concerning internal/external compliance requirements
• Maintains and enhances knowledge of industry standards through effective knowledge-sharing
• Develops publishing strategy to improve business process and/or address publishing issues without significant impact to timeline and resources
• Demonstrates proficient skills concerning utilizing publishing tools and serves as a credible resource to others
• Accountable for accomplishing objectives/goals and takes initiative to improve performance to align with expectations
• Anticipates potential barriers in achieving objectives/goals and acts to correct plans to ensure that goals are met with reasonable timelines
• Drives high standards of publishing quality and utilizes various techniques, and critical thinking, to achieve desired results
• Collaborating effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.

• Adapts to customer\'s perspectives to anticipate, and consistently meet, their needs as well as continuing to strengthen customer relationships
• Clearly and convincingly communicates, and effectively resolves critical submission processing issues
• Conducts peer reviews and provides feedback to support performance improvement
• Motivates and works collaboratively with team members to raise awareness, provide feedback, and improve department processes
• Train new publishers on business process and systems
• Ensures immediate manager is aware of activities and current status/progress
• Managing the workload within their realm of authority and autonomy
• Projects a professional, respectful, and cooperative demeanor at all times
• Performs additional tasks and duties as assigned by immediate manager

qualifications:

• A BS / BA is preferred and 2-4 years of regulatory publishing experience in the pharmaceutical industry; preferably eCTD experience
• Understanding of the CFR, FDA/ICH guidelines and cGMP\'s, as it pertains to electronic submission processing
• Proficient computer skills especially with Microsoft and Adobe Acrobat applications.
• Detail-oriented and effective organizational skills
• Strong verbal and written communication skills
• Strong teamwork skills; self-motivated; strong work ethics
• Ability to maintain confidentiality

skills: FDA, MS-WORD, ICH Regulations, GMP (Good Manufacturing Practice)

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.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate\'s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Randstad