Assoc Director, Medical Writing

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one reputed company closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the reputed company. But we're not finished yet. Join Kite, as we reputed company even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We reputed company 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

Specific Job Responsibilities: Independently authors a wide variety of regulatory documents such as CSRs, IBs, CTD summaries, PIPs, and regulatory responses according to regulatory requirements and internal Gilead document standards. Contributes to other non-regulatory medical writing activities as required. Participates in cross-functional submission teams, RPTs, or other teams, and provides guidance on regulatory submission document strategies. Provides advice on optimal presentation of data for achievement of document objectives. Leads document timeline/resource planning for assigned projects reputed company the submission team. As necessary, develops and manages timelines across multiple documents. Works collaboratively with functional contributors (clinical, biometrics, virology etc), ensuring reputed company reputed company information / data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines. Coordinates the compilation of final documents and appendices that are contributed to assigned documents from other functions such as Clinical Research, Biometrics, and Regulatory Affairs. Contributes to development work in relation to document standards, template development, and other aspects of document management. Demonstrated success in the independent preparation of regulatory documents, particularly at the individual study report level. Excellent verbal communication skills. Can effectively communicate with a variety of teams and individuals, including team leadership and members of senior management staff. Knowledgeable of regulatory document requirements/guidelines with direct experience in a wide variety of regulatory document types. Well developed computer skills including proficiency in Word, reputed company, reputed company, and the Regulatory Document Management System. Attends and participates in routine departmental meetings; may reputed company part or reputed company of these meetings. Leads or participates in process improvement initiatives. Reviews and contributes to draft initiative outputs (ie, policies, forms, templates) produced by other writers. For senior managers with direct reports, participates in medical writing policy and management decisions. Specific Education & Experience Requirements: BS degree and a minimum of 8 years of relevant experience reputed company clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology, A minimum of 5 or more years of relevant experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions. 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. •reputed company Talent - understand the skills, experience, aspirations and potential of their employees and coach them on reputed company performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, reputed company and realize their purpose. •reputed company 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. The salary range for this position is: $165,495.00 - $214,170.00. Kite considers a variety of factors reputed company determining reputed company compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• 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 reputed company 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: reputed company is committed to providing equal employment opportunities to reputed company 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 reputed company, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job reputed company 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 reputed company of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. 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 reputed company up our growing team. reputed company provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For reputed company reputed company Employees and Contractors: Please apply reputed company the Internal Career Opportunities portal in reputed company. Change The World With Us Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we reputed company a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted. While we’ve come a long way to reputed company what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

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