Sr Medical Writing Associate

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet.

Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

This role is located in Santa Monica CA.

As Sr Medical Writing Associate you will be responsible for the following.

Key Responsibilities:

• Prepare regulatory documents such as Phase 1 and Phase 2 Clinical Study Reports (CSRs) and Investigators Brochures (IBs) in compliance with regulatory requirements and internal standards.
• Work under the guidance of senior medical writers while independently managing projects of limited complexity.
• Assist in the development of additional document types including Phase 3 CSRs pediatric investigation plans and regulatory response documents under close supervision.
• Contribute to non-regulatory medical writing activities as needed.
• Represent the medical writing function on product or project teams with oversight from senior staff.
• Participate in submission teams offering guidance on data presentation to meet document objectives.
• Support planning and resource allocation for assigned documents including timeline reviews.
• Collaborate with cross-functional teams (e.g. Clinical Research Biometrics Virology) to ensure accuracy completeness and scientific integrity of source data.
• Coordinate final document compilation ensuring all functional area contributions are complete and integrated.
• Contribute to the development and maintenance of document templates standards and medical writing processes.
• Build expertise in regulatory document preparation particularly at the individual study report level.
  

Basic Qualifications:

• Bachelors degree required; advanced degree in life sciences preferred.
• 5 Years with BS/BA
• 3 Years with MS/MA
  

Preferred Qualifications:

• Bachelors degree (BS) in a relevant scientific discipline.
• Minimum of 3 years of experience in clinical research and development (R&D) or regulatory affairs within the pharmaceutical or biotechnology industry.
• At least 1 year of direct experience in medical writing or clinical submissions including preparation of documents for regulatory submissions.
• Strong verbal communication skills and meticulous attention to detail.
• Adaptable communication style to effectively engage with diverse team members.
• Solid understanding of regulatory document requirements and industry guidelines.
• Proficiency in Microsoft Word Adobe Acrobat Excel and document management systems (e.g. RDMS).
• Active participation in departmental meetings and collaborative initiatives.
  

People leader accountabilities

• Create inclusion - knowing the business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.
• Develop talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow develop and realize their purpose.
• Empower teams - connect the team to the organization by aligning goals purpose and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 for assistance.

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