Senior RA/Technical Writer

2 weeks ago


Santa Monica, California, United States Collabera Full time


  1. Home
  2. Search Jobs
  3. Job Description
Senior RA/Technical Writer (CMC) - Remote Contract: Santa Monica , California, US Salary Range: 60.00 - 85.00 | Per Hour Job Code: 360658 End Date: 2025-05-07
Days Left: 28 days, 3 hours left Apply Position Details: Industry: Pharmaceutical Job Title: Senior RA/Technical Writer (CMC) - Remote Duration: 12+ Months (+Potential for extension) Pay Range: $60-$85/hr (Based on experience level) Description:
  • We are 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 time 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):
  • 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.
Qualifications :
  • 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
Job Requirement
  • Technical Witing
  • Technical Writer
  • CMC
  • Chemistry Manufacturing and Control
  • Module 3
  • Stability
  • method eevelopment
  • biologics
  • biologicals
  • biotechnology
  • cell therapy
  • gene therapy
  • CAR-T
  • aseptic techniques
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Niharika Shrivastava
  • niharika.shrivastava@collabera.com
Apply Now Collabera

  • Santa Monica, California, United States ACL Digital Full time

    Title: Technical Writer - II Location: RemoteDuration: 06 months with possible extension Job Summary: We are seeking a skilled Technical Writer to create and maintain documentation related to Protected Health Information (PHI), Good Practice (GXP) guidelines, and healthcare quality standards. The ideal candidate will have a strong background in healthcare...


  • Santa Monica, California, United States ACL Digital Full time

    Title: Technical Writer - II Location: RemoteDuration: 06 months with possible extension Job Summary: We are seeking a skilled Technical Writer to create and maintain documentation related to Protected Health Information (PHI), Good Practice (GXP) guidelines, and healthcare quality standards. The ideal candidate will have a strong background in healthcare...

  • Pharmaceutical Writer

    2 weeks ago


    Santa Monica, California, United States Collabera Full time

    Job DescriptionCollabera is hiring a skilled Senior RA/Technical Writer (CMC) to support our Process Development organization. As a key member of the team, you will contribute to time-critical CMC regulatory submissions and develop high-quality content.About the JobThis 12+ month contract offers a competitive hourly rate of $60-$85 based on experience level....

  • Technical Writer

    5 days ago


    Santa Monica, California, United States RICEFW Technologies Inc Full time

    Job Description: Job Title: Technical Writer 2 100% Remote Job Summary: We are seeking a skilled Technical Writer to create and maintain documentation related to Protected Health Information (PHI), Good Practice (GXP) guidelines, and healthcare quality standards. The ideal candidate will have a strong background in healthcare regulations,...

  • Technical Writer

    4 days ago


    Santa Monica, California, United States Tranzeal Incorporated Full time

    Role: Technical Writer II Location: Santa Monica, CAOverview: We are looking for an experienced Technical Writer II to join our team in Santa Monica, CA. This role will focus on developing and maintaining high-quality documentation related to Protected Health Information (PHI), Good Practice (GXP) guidelines, and healthcare quality standards. The right...

  • Technical Writer

    7 days ago


    Santa Monica, California, United States ATR International Full time

    Job Description: Job Summary: We are seeking a detail-oriented and experienced Technical Writer to create comprehensive and user-friendly software user guides The ideal candidate will have a strong understanding of software applications, excellent writing skills, and the ability to translate complex technical information into clear and concise...

  • Technical Writer 3

    7 days ago


    Santa Monica, California, United States RICEFW Technologies Inc Full time

    Job Description: Job Title: Technical Writer 3 Job Summary: We are seeking a detail-oriented and experienced Technical Writer to create comprehensive and user-friendly software user guides. The ideal candidate will have a strong understanding of software applications, excellent writing skills, and the ability to translate complex technical information...

  • Technical Writer 3

    6 days ago


    Santa Monica, California, United States RICEFW Technologies Inc Full time

    Job Description: Job Title: Technical Writer 3 100% Remote Job Summary: We are seeking a detail-oriented and experienced Technical Writer to create comprehensive and user-friendly software user guides. The ideal candidate will have a strong understanding of software applications, excellent writing skills, and the ability to translate complex...

  • Technical Writer

    4 days ago


    Santa Monica, California, United States Net2Source Inc. Full time

    Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap –...

  • Technical Writer

    8 hours ago


    Santa Monica, California, United States Net2Source Inc. Full time

    Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap –...

  • Technical Writer 3

    11 hours ago


    Santa Monica, California, United States RICEFW Technologies, Inc. Full time

    Job Description:Job Title: Technical Writer 3100% Remote Job Summary: We are seeking a detail-oriented and experienced Technical Writer to create comprehensive and user-friendly software user guides. The ideal candidate will have a strong understanding of software applications, excellent writing skills, and the ability to translate complex technical...


  • Santa Monica, California, United States Careers Integrated Resources Inc Full time

    Careers Integrated Resources Inc is looking for a Senior Regulatory Writer to join our team. As a key member of our Process Development organization, you will play a critical role in supporting our internal teams and contributing to our growth pipeline projects.This position requires a highly motivated individual with late-phase CMC technical experience,...

  • Technical Writer

    2 weeks ago


    Santa Monica, California, United States Intelliswift Software Full time

    Job ID: 25-08218 Title: CMC Technical Writer Author and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts •Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology,...

  • Technical Writer

    2 weeks ago


    Santa Monica, California, United States Leadstack Inc Full time

    LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world. Job...

  • Technical Writer

    12 hours ago


    Santa Monica, California, United States Maxonic Inc. Full time

    Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Technical Writer - IIIJob Description:Job Title: Technical Writer - IIIJob Location: Santa Monica, CAWork Schedule: On-siteStarting rate: $80/h W2, Based on experienceDescription:The client is seeking a highly motivated individual with...

  • CMC Technical Author

    2 weeks ago


    Santa Monica, California, United States Collabera Full time

    Job OverviewCollabera is seeking a skilled Senior RA/Technical Writer (CMC) to support our Process Development organization. As a key member of the team, you will contribute to time-critical CMC regulatory submissions and develop high-quality content.About the PositionThis 12+ month contract offers a competitive hourly rate of $60-$85 based on experience...


  • Santa Monica, California, United States Net2Source Inc. Full time

    Job Description:Job Title: CMC Technical Writer Location: Santa Monica, CA 90404 (50% Remote) Duration: 06+ Months (Extendable)Pay Rate: $80.00 – 85.00/hr. on W22 openings.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...


  • Santa Monica, California, United States LeadStack Inc. Full time

    Technical Writer - III Location: Santa Monica, CA - Remote Duration: 8 months contract PR: $60/hr to $80/hr Seeking a highly motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience. In the near-term, this role will support time critical CMC Regulatory submissions. Longer-term, this...

  • Technical Writer

    3 weeks ago


    Santa Monica, California, United States Pacer Group Full time

    Job Position – CMC Technical WriterLocation – Santa Monica, CA 90404Duration – O8 MonthsDescription: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...

  • Technical Writer

    2 weeks ago


    Santa Monica, California, United States Integrated Resources, Inc. Full time

    Job Title: Technical Writer - IIILocation: Santa Monica, CA (Hybrid)Duration: 6+ Months (Possible Extension)Pay range: $80/hr. on W2Job 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...