DIRECTOR, REGULATORY WRITING

Company: CARGO-Therapeutics
Location: San Mateo
Posted on: March 10, 2023

Job Description:

POSITION SUMMARY -
Reporting to the Vice President, Regulatory Affairs, CARGO is hiring a Director, Regulatory Writing to grow a global regulatory writing function for our cell therapy portfolio.This person will be responsible for development of US and rest of world regulatory submission documents for CARGO's cell therapy pipeline. The individual must have deep knowledge of regulatory submission requirements in major regions (US, EU) and people management experience. Reporting to the VP, Regulatory Affairs, the successful candidate will work closely with colleagues in regulatory, research, clinical development, safety, and biostatistics, as both the group leader and an individual contributor, for the development of complex documents supporting IND, BLA, clinical/scientific publications/communications, and other regulatory submissions. This individual will also develop needed infrastructure and processes needed for a successful medical writing department.The role is based in San Mateo, CA but is also suitable for a hybrid or remote work arrangement. -WHAT YOU'LL DO AT CARGO THERAPEUTICS - - - - - - - - Lead and individually contributes to the medical writing activities for a variety of clinical, regulatory documents, including, but limited to briefing documents, clinical protocols, module 2 clinical and nonclinical summaries, investigator brochures (IBs), safety narratives, annual reports, and other clinical and regulatory documents - - - - - - - In collaboration with cross-functional colleagues, lead development of related clinical and scientific communications, such as abstracts, posters, presentations, and manuscripts - - - - - - - Key participant on teams working directly with clinical study managers, medical directors, safety officers, scientists, biostatisticians, regulatory leads, and project managers to ensure proper planning and tracking to meet project deadlines - - - - - - - Develop standardization of document templates and company style guide to ensure the quality and consistency across programs - - - - - - - Ensure documents that are well organized, accurate, consistent, and in compliance with applicable company SOPs and style standards and local and national regulations, including ICH-GCP - - - - - - - Recruit, hire, and develop junior in-house writers; source, hire, and manage contract writers - - - - - - - Interact closely with external vendors (e.g., publishers) to achieve on-time regulatory submissions - - - - - - - Core contributor on global regulatory filings, to include INDs and BLA/MAA license applications -THE RIGHT STUFF: Required Experience & Qualifications - - - - Minimum of Bachelor's degree in a scientific, medical or clinical discipline with 3-5 years' pharmaceutical/biotechnology-related medical writing experience; Advanced degree preferred - - - Demonstrated superior scientific writing and analytical skills - - - Direct medical writing experience supporting license applications (BLA, NDA) with focus on M2 and M5 of the CTD - - - Advanced knowledge of FDA, EMA and ICH guidelines and regulatory requirements - - - Extensive experience with eCTD development, publishing, and submission - - - Therapeutic experience in biologics, specifically cell therapy, preferred - - - Strong history of prioritizing and multi-tasking multiple projects in a fast-paced environment using excellent time management skills - - - Adept at working autonomously, as well as collaboratively in a team - - - Demonstrated leadership of direct-reports, contractors, and cross-functional teams
PAY RANGE*The combined pay range for the Director, Regulatory Writing is from $181,290-$250,140. 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, formerly Syncopation Life Sciences, is advancing a new generation of adoptive cell therapies for cancers. Our lead program is addressing a primary mechanism of resistance and relapse to the currently available Chimeric Antigen Receptor T-cell (CAR T) therapies. Despite advances made by commercially available autologous CARs, these treatments are only curative for less than half of all cancer patients. In addition, far too many patients are unable to access these---potentially curative therapies due to other challenges, including manufacturing, supply,---time,---and reimbursement. CARGO Therapeutics is actively working on novel solutions to achieve better outcomes and experiences.---Our mission is to outsmart cancer and develop the next generation of best-in-class CARs. Beyond our lead program, our platform technologies enable the---multiplex---engineering necessary to overcome multiple mechanisms of tumor resistance, to counter inhibition by solid tumors, and in the allogeneic setting to evade immune rejection. - We have the capability to incorporate complex therapeutic CARGO Therapeutics into our CARs, with the potential to achieve durable responses that are curative for more patients. ---Our founders are pioneers and world experts in CAR T cell therapy, and we have built a team with experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. CARGO Therapeutics colleagues share a passion to help others thrive.--- We are tenacious in the relentless pursuit of our mission, and we innovate to change the game for the patients we serve. - -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 requires 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. - -

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