Integrated Resources is hiring : Technical Writer - III in Santa Monica

Job Title : Technical Writer - III

Location : Santa Monica, CA (Hybrid)

Duration : 6+ Months (Possible Extension)

Pay range : $80 / hr. on W2

Job Description :

Client is seeking a highly motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience. This position is part of the Process Development organization and in this role, this individual will be supporting the internal Process Development teams. In the near-term, this role will support critical CMC Regulatory submissions. Longer-term, this individual will be embedded in technical teams within the Process Development department supporting CMC aspects of our growing pipeline projects.

Responsibilities (include but are not limited to) :

• uthor and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts.
• Experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, awareness of ICHs and global compendial requirements governing analytical development and characterization / comparability of Advanced Therapy Medicinal Products and vector intermediates.

Requirements :