What are the responsibilities and job description for the Technical Writer - III position at Cube Hub, Inc.?
Job Details
Job Summary:
1. The role requires a motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience.
2. The job is part of the Process Development organization, supporting internal Process Development teams.
3. The individual will be involved in time-critical CMC Regulatory submissions.
4. The role includes authoring and finalizing appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts.
5. The position requires experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, and awareness of ICHs and global compendial requirements.
6. The job requires a Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with relevant experience.
7. The role requires experience in CMC/Module 3 regulatory submissions and technical writing.
8. The individual must have knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process development.
9. Knowledge of product lifecycle and regulatory requirements for biologics, pharmaceuticals and medical devices is essential.
10. The role requires excellent communication skills, the ability to think critically, problem-solving skills, and self-motivation.
11. The individual must be willing to accept temporary responsibilities outside of the initial job description and must be comfortable in a fast-paced environment with minimal direction.
12. Proficiency in Microsoft office applications and excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
13. The job is based onsite.
1. The role requires a motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience.
2. The job is part of the Process Development organization, supporting internal Process Development teams.
3. The individual will be involved in time-critical CMC Regulatory submissions.
4. The role includes authoring and finalizing appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts.
5. The position requires experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, and awareness of ICHs and global compendial requirements.
6. The job requires a Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with relevant experience.
7. The role requires experience in CMC/Module 3 regulatory submissions and technical writing.
8. The individual must have knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process development.
9. Knowledge of product lifecycle and regulatory requirements for biologics, pharmaceuticals and medical devices is essential.
10. The role requires excellent communication skills, the ability to think critically, problem-solving skills, and self-motivation.
11. The individual must be willing to accept temporary responsibilities outside of the initial job description and must be comfortable in a fast-paced environment with minimal direction.
12. Proficiency in Microsoft office applications and excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
13. The job is based onsite.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
