As the world's 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. 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!
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: North Chicago, Illinois
job type: Contract
salary: $35.00 - 43.56 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Project manage the overall Chemistry and Manufacturing Control (CMC) Variation process. This includes documenting the agreed-upon regulatory strategy for the CMC change, managing the authoring, reviewing, and approving of the submission documents, and maintaining the timeline.
- Work proficiently in the document approval and archiving repository
- Work with regulatory operations in providing the appropriate documentation for the global roll-out of the CMC Variation.
- Work proficiently in a document approval and archiving repository
- Ensure submission documents are submission-ready formatted.
- Interfaces with Operations CMC Team and Quality Assurance
- Contribute to a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels
- Communicate to the Regulatory Affairs (RA) CMC Project Lead any questions or concerns for meeting the timelines
- Balance multiple priorities in a fast-paced, team-based environment and work independently when needed
qualifications:
- Required: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject.
- 7 years' experience
- Scientific background and knowledge of project management is desirable
- Quick learner of technology applications
- Expertise in MS Office applications including Excel, Word and Sharepoint
- Excellent oral and written communication skills in English
- Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills
- Competent in application of standard business procedures (standard operating procedures,)
- Ability to work with minimal supervision
- Learns fast, grasps the "essence" and can change course quickly when required
- Preferred: Experience in pharmaceutical business and/or science
skills: Project Management, CMC, MS-WORD, MS-EXCEL, MS-Project
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.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
