Shift (1shift, M-F) 8am-5pm
location: Colorado Springs, Colorado
job type: Permanent
salary: $55,000 - 68,000 per year
work hours: 8 to 4
education: Bachelors
responsibilities:
- Edit and write Pharmaceutical Development and R&D Quality system policy, procedure, work instructions and other supporting documents
- Drafts CMC sections of regulatory filings, manage submission projects and keep supporting documentation files organized and up to date
- Interact with Formulation and Analytical Development SMEs in R&D to support and/or write documents/reports/laboratory instructions that are accurate and usable
- Work with Regulatory Groups in managing their regulatory submissions
- Manage and support the document development, maintenance and change request process for multiple documents simultaneously
- Analyze documents and documents sets to identify opportunities for improvement
- Manage multiple, sometimes conflicting priorities
- Other responsibilities as assigned
qualifications:
- Bachelor of Science degree in a Life or Physical Science
- 5+ years related experience, or equivalent combination of education and experience; or Master of Science degree in a life or physical science plus publication and at least 1 year laboratory experience also considered
- Excellent verbal and proven written communication skills
- Able to handle multiple high priority documents/projects simultaneously
- Able to interact effectively at various levels within the organization, with our customers and other external contacts
- Working knowledge of CMC sections in Module 3 sections of regulatory filings and eCTD (electronic common technical document)
- Fluent in MS Office and familiar with CMC documentation in the CTD format
- Abel to quickly learn complex business processes and specialized terminology
- Abel to work both independently and collaboratively with little supervision
- Able to work in a changing environment with changing priorities
skills: Editing, Biology, QC Review
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 Colorado Residents Only: The hourly range for Colorado residents is $15.00 to $25.00/hour. Pay is based on several factors including but not limited to education, work experience, certifications, etc. In addition to your salary, Randstad offers a comprehensive benefits package, incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
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.
