Technical Writer III
Collabera Inc.
Marketing & Communications, IT
Santa Monica, CA, USA
USD 70-80 / hour
Posted on Aug 13, 2025
Technical Writer III
Contract: Santa Monica, California, US
Salary Range: 70.00 - 80.00 | Per Hour
Job Code: 364397
End Date: 2025-09-11
Days Left: 28 days, 11 hours left
Pay Range: $70 - $80/hour
Position Details:
Industry: Pharmaceutical
Position Title: Technical Writer III
Duration: 6 months (Possible extensions)
Location: Santa Monica, CA 90404
Job Description:
- Author 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:
- Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant experience
- Experience CMC/Module 3 regulatory submissions
- Experience in technical writing and proficient in high quality writing
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process development
- Thorough knowledge of biologics analytical and process development is essential. Cell therapy process development experience is highly desired
- Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing
- Working knowledge of regulatory requirements for biologics, pharmaceuticals and medical devices
- Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Well-developed computer skills and fluent with MS office applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)
Job Requirement
- Technical Writer
Reach Out to a Recruiter
- Recruiter
- Phone
- Himanshu Singh
- himanshu.ksingh@collabera.com