As the world's largest staffing and recruitment agency, we are dedicated to helping you find the ideal role that offers growth and development opportunities within the life sciences sector. By working with a recruiter, you gain access to a vast network of leading employers and detailed insights into a wide range of positions. One of our premier partnerships is with a research-driven biopharmaceutical powerhouse focused on developing treatments for complex, hard-to-cure diseases. This esteemed company has brought 32 groundbreaking products to market, including Humira and Lupron, making a significant global impact. If you're ready to make your mark in the field and contribute to the future of innovative therapies, this is the opportunity for you!
location: North Chicago, Illinois
job type: Contract
salary: $30.00 - 34.57 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Responsible for managing and compiling CMC sections of marketed product variations.
- Partner with RA CMC Project Leads and develop module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
- Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
- Skills for running review meetings for submission documents.
- Understand CMC expectations including CTD content, structural and formatting requirements.
- Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
- Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
- Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
- Independently facilitate project team meetings.
- Superior oral and written communication skills
- Ability to work cooperatively with all levels and types of global personnel required
- Experience working with electronic document management systems
- Ability to work independently. Manage multiple projects simultaneously.
- Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.
- Detail/accuracy oriented, collaborative and willing to learn
- Familiarity with US and other international regulatory requirements for dossiers
qualifications:
- Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
- Required Experience: 4 years pharmaceutical. 1-2 years cross functional project management
- Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
skills: CMC, CTD Structure, Submissions
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).
This posting is open for thirty (30) days.
