Documentation Specialist (CMC)

Job description

Location: Remote (8am - 4:30pm Central Time Zone)

Contract Length: 6 Months (potential for extension)

Pay Rate: $33-38/hr including individual healthcare coverage

This position will be responsible for management of CMC and Device Post Approval Changes and Agency responses for company product portfolio.

Job Requirements:

• Experience project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents
• Strong working knowledge of manufacturing unit operations or CTD structure- specifically, experience with CMC Module 3 within eCTD
• Experience working with electronic document management systems
• Ability to work independently under pressure and manage multiple projects simultaneously

Education/Experience:

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline.
• 4 years pharmaceutical or industry related experience.
• 1-2 years in quality systems or cross functional project management

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.