Content Specialist in industrial automation marketing team creating compelling content that drives brand awareness and sales enablement through diverse platforms.
About the role
- Senior STEM Content Analyst responsible for CMC reports and regulatory compliance in Life Sciences. Collaborating with global teams and leveraging AI in a hybrid work environment.
Responsibilities
- Author high‑quality CMC reports for Small Molecules and Biologics to support regulatory submissions
- Monitor and analyze global CMC regulatory changes and update internal databases
- Serve as the internal CMC regulatory expert for assigned countries and support the CMC Product Manager
- Provide subject‑matter expertise to guide and validate AI‑assisted content generation and collaborate with AI‑enabled workflows
- Work with Product, Tech, Customer Care, and other stakeholders, and participate in special projects and editorial/content operations
Requirements
- BS degree in Life Sciences (Pharmacy, Chemistry, Biochemistry, Biotechnology)
- Minimum of 5+ years in pharmaceutical development, CMC manufacturing, or CMC regulatory affairs for Small Molecules and/or Biologics
- Proven authorship/review of CTD/eCTD Module 3 (3.2.S / 3.2.P) and Module 2.3/QOS
- Familiarity with NDA/ANDA/BLA/MAA and post‑approval changes
- Experience managing BLA/MAA content and FDA/EMA submissions, including deficiency responses and quality‑related communications
- Solid knowledge of complex CMC regulatory requirements and ICH quality guidelines for Small Molecules and Biologics
- Proven ability to work effectively in global, multicultural, and remote teams
- Strong communication, problem‑solving, and decision‑making skills
- Fluency in English with additional languages as an advantage
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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