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Senior Manager, Regulatory Writing

Expired Job

Kite Pharma, Inc. Santa Monica , CA 90405

Posted 5 months ago

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

The Senior Manager, Regulatory Writing will report to the Director of Regulatory Writing. In this individual contributor role, the regulatory writer will be responsible for writing and/or editing clinical documents for INDs, BLAs, MAAs, and associated regulatory submissions.

Roles and Responsibilities (including, but not limited to):

  • Serve as medical writing contributor or lead for clinical trial-related regulatory documents

  • Write/edit/review content of clinical trial-associated documents for new and ongoing programs

  • Work with cross-functional teams to ensure production of high-quality written documents

  • Perform literature searches as needed, and summarize data for incorporation into documents

  • Adhere to company Style Guide, templates, and SOPs for document development

  • Commit to company timelines for all assigned documents

Requirements:

  • Doctorate in life sciences preferred; other relevant experience considered

  • 5+ experience in regulatory writing or equivalent experience

  • Strong scientific background in cellular immunology or related field, or oncology

  • Experience with clinical trial protocols, investigator's brochures, clinical study reports, safety narratives, other safety reports, or CTD clinical summaries

  • Knowledgeable of US and international regulations

  • Demonstrated advanced writing skills , with strong command of English language and grammar

  • Proficiency with MS Office Suite, Endnote, and MSWord templates

  • Strong oral and written communication skills

  • Efficient, organized, and able to handle short timelines in a fast-paced environment

  • Ability to work both independently and collaboratively

  • Ability to identify issues, ask questionss, and propose solutions

NOTE: This position will be onsite in Santa Monica, or can be considered for a remote option.

#LI-JK2

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For jobs in France:

Conformment la Loi " Informatique et Liberts " (06/01/78), nous vous informons du fait que les donnes personnelles renseignes pourront faire l'objet d'un traitement informatique par Gilead et pourront tre transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accs, de rectification et de suppression des donnes vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


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Senior Manager, Regulatory Writing

Expired Job

Kite Pharma, Inc.