job summary: 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: Lake Bluff, Illinois job type: Contract salary: $50.00 - 59.05 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 repositoryWork 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 repositoryEnsure submission documents are submission-ready formatted.Interfaces with Operations CMC Team and Quality AssuranceContribute to a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levelsCommunicate to the Regulatory Affairs (RA) CMC Project Lead any questions or concerns for meeting the timelinesBalance 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' experienceScientific background and knowledge of project management is desirableQuick learner of technology applicationsExpertise in MS Office applications including Excel, Word and SharepointExcellent oral and written communication skills in EnglishOrganization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skillsCompetent in application of standard business procedures (standard operating procedures,)Ability to work with minimal supervisionLearns fast, grasps the essence and can change course quickly when requiredPreferred: Experience in pharmaceutical business and/or science skills: CMC, MS-WORD, MS-EXCEL, Biology, Chemistry 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. 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.