- Review technical reports as required by CMC function leaders in preparation for submission authoring
- Author, compile, and manage CMC sections for a wide variety of regulatory submissions including, but not limited to, IND, IMPD, QOS, Briefing books, BLA and MAA
- Effectively communicate and manage the integrated document drafting and reviewing process following meeting filing timelines
- Collaborate effectively with Technical SMEs to prepare CMC sections of the regulatory dossiers
- Develop standardization of document templates and company style guide to ensure quality and consistency across programs
- Ensure documents are well-organized, accurate, consistent, and in compliance with applicable Company SOPs and style standards and local and national regulations
- Minimum of Bachelor's degree in a scientific or engineering discipline with 6 years' CMC writing experience
- Direct writing experience supporting license applications (MAA/BLA, IND/IMPD) with focus on M2 and M3 of the CTD
- Extensive experience with eCTD development, publishing, and submission of regulatory documents
- Therapeutic experience in biologics essential, with a strong preference for experience authoring cell-based gene therapy applications
- Strong planning and organizational skills with a history of prioritizing and multitasking multiple projects in a fast-paced environment using excellent time management skills
- Adept at working autonomously, as well as collaboratively in a team
-
Cmc Technical Writing Manager
3 weeks ago
Orca Bio Menlo Park, United StatesOver one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease. · **Summary* ...
-
Senior Manager, Technical Writing
1 week ago
Cargo Therapeutics, Inc. San Carlos, United StatesReporting to the Director, Technical Writing, CMC Regulatory, CARGO is hiring a Senior Manager, Technical Writing to join the Technical (CMC) Regulatory writing function to help progress our cell-based gene therapy portfolio. · This person will be responsible for the authoring of ...
-
Senior Manager, Technical Writing
1 week ago
Cargo Therapeutics, Inc. San Carlos, United StatesReporting to the Director, Technical Writing, CMC Regulatory, CARGO is hiring a Senior Manager, Technical Writing to join the Technical (CMC) Regulatory writing function to help progress our cell-based gene therapy portfolio. · This person will be responsible for the authoring o ...
-
Senior Manager, Technical Writing
3 weeks ago
Cargo Therapeutics San Carlos, United StatesJob Description · Job DescriptionReporting to the Director, Technical Writing, CMC Regulatory, CARGO is hiring a Senior Manager, Technical Writing to join the Technical (CMC) Regulatory writing function to help progress our cell-based gene therapy portfolio.This person will be re ...
-
CMC Technical Writing Manager
5 days ago
Mediabistro Menlo Park, United StatesScience – Chemistry, Manufacturing & Controls / · Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditio ...
-
Research Associate, Pharmaceutical Sciences
1 week ago
Osanni Bio, Inc. San Carlos, United States**Who we are**: · Osanni is Designed for Sight. We are creative & agile innovators, passionate about developing breakthroughs to save eyesight. · At Osanni we are creating a uniquely different biotech company with the talent and unconventional thinking to deliver therapies to pre ...
-
Marketing Specialist
1 week ago
S.J. Amoroso Construction Redwood Shores, United States**Essential Job Functions** · - Assist in the development and submission of prequalification packages, statements of qualifications, technical proposals, presentations, resumes, project descriptions, and other deliverables to public works and private clients. · - Participate in t ...
-
Lead Analyst, R&D Technical Writing
2 weeks ago
Dimensional Thinking Fremont, United StatesEssential Duties & Responsibilities (detailed description): · Strong attention to detail, reviews and audits other technical publications deliverables and consistently delivers quality documentation with no escapes · Leads structured problem-solving initiatives to resolve complex ...
-
Principal Software Developer
3 weeks ago
Oracle Redwood City, United StatesFor this new Spectra architecture, we're building data extraction services, that is highly scalable, performant and resilient. This is a startup team and comes with a service ownership role that is hands-on, with lots of opportunity for large contributions and impact across the o ...
-
Business Systems Analyst
2 weeks ago
Electronic Arts Redwood City, United StatesThe future of entertainment is interactive, and our Marketing team plays an important role in this future by building content, culture, and community around our brands. We empower audiences to Play, Create, Watch, and Connect across our amazing franchises and experiences, includi ...
-
Sales & Marketplace Operations Manager
2 weeks ago
Zūm Services Redwood City, United StatesReporting to the VP, Charter Services, the Sales & Marketplace Operations Manager will help drive the growth of this new and critical part of the company. It's an opportunity to join this team at the ground floor and drive a real impact as we build out the business in our current ...
-
Workday Integration Developer with Benefits
1 week ago
Caltek Solutions Inc Redwood City, United StatesJob Description: · Key Responsibilities: · **Responsibilities**: · - Design, develop, and test integrations between Workday and other systems using Workday's integration tools and technologies, including Studio, EIB, Connectors, XML, XSLT, and Workday web services. Must have hand ...
-
Principal Scientist
3 days ago
Cargo Therapeutics San Carlos, United StatesCARGO Therapeutics is engineering best-in-class CAR T-cell therapy to overcome resistance to cancer treatment and address barriers to access so that more patients may benefit from potentially curative therapies. CARGO is on a mission to outsmart cancer by advancing a new generati ...
-
Technical Writer
3 weeks ago
Autonomous Vehicle Company Foster City, United States**Technical Writer - remote** · **Responsibilities** · - Collaborate with engineering, product management, and other stakeholders to gather information and understand technical concepts. · - Create and maintain technical documentation, including user manuals, API documentation, r ...
-
Technical Writer
3 weeks ago
Ryzen Solutions Foster City, United States**Responsibilities** · - Collaborate with engineering, product management, and other stakeholders to gather information and understand technical concepts. · - Create and maintain technical documentation, including user manuals, API documentation, release notes, troubleshooting gu ...
-
Supervisor, Clinical Laboratory
5 days ago
Exact Sciences Corporation Redwood City, United States**Help us change lives** · At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, ...
-
Machine Learning Scientist
5 days ago
Observe Redwood Shores, United States**About Us** · - Observe.AI is the fastest way to boost contact center performance with live conversation intelligence. Built on the most accurate AI engine in the industry, Observe.AI uncovers insights from 100% of customer interactions and maximizes frontline team performance t ...
-
Spotfire Developer
2 weeks ago
Diverse Lynx Foster City, United StatesAtleast 5 years of experience in Spotfire Dashboard creation · - Should able to create data functions in Spotfire and use them in analysis · - Should create inbuilt visualizations with SELECT Information Links and SELECT Custom Queries · - Should be able to write complex Scripts ...
-
Haven Program Manager
1 week ago
Kensington Senior Living, LLC Redwood City, United States**Summary**: · The Haven Program Manager is responsible for all aspects of the operation of the Memory Care neighborhood including planning, organizing, developing, directing, and evaluating services and programs in a manner that meets the needs and interests of Memory Care resid ...
-
Quality Systems Specialist Ii
2 weeks ago
Gilead Sciences Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your · Internal Career Site · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to dev ...
Senior Manager, Technical Writing - San Carlos, United States - Cargo Therapeutics
Description
Reporting to the Director, Technical Writing, CMC Regulatory, CARGO is hiring a Senior Manager, Technical Writing to join the Technical (CMC) Regulatory writing function to help progress our cell-based gene therapy portfolio.
This person will be responsible for the authoring of US, EU and rest of world Technical (CMC) regulatory submission documents in support of CARGO's cell-based gene therapy pipeline. The individual must have deep knowledge of Module 3 submission content requirements in major regions (US, EU) and will ideally have worked on biologic marketing applications. The successful candidate will work closely with colleagues in Regulatory, Quality, Technical Operations, and Translational Medicine in the development of documents supporting IND, IMPD, MAA, BLA, meeting briefing documents, and other regulatory submissions.
The role is onsite in San Carlos, CA.
WHAT YOU'LL DO AT CARGO THERAPEUTICS
The combined pay range for this role is $132,000 - $182,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.
ABOUT CARGO THERAPEUTICS
CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic "cargo" designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-
Join us to help make a difference
EEO & EMPLOYMENT ELIGIBILITY
CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.
CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
