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25 days old

Pharmaceutical Technical Writer

Kelly Services
Colorado Springs, CO 80932
  • Jobs Rated
    43rd
Pharmaceutical Technical Writer


Direct Hire


8-5


70K per year


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



**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Jobs Rated Reports for Technical Writer

Posted: 2022-04-25 Expires: 2022-05-26

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Pharmaceutical Technical Writer

Kelly Services
Colorado Springs, CO 80932

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Technical Writer
43rd2019 - Technical Writer
Overall Rating: 43/199
Median Salary: $71,815

Work Environment
Very Good
32/220
Stress
Medium
93/220
Growth
Fair
91/220
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