Senior Associate, Regulatory Writing
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Job Detail
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Job Description
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 develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
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 Gilead and help create possible, together.
Job Description
The Senior Associate, Regulatory Writing will be responsible for writing and/or editing clinical documents for INDs, BLAs, MAAs, and associated regulatory submissions. This is an individual contributor role.
Job Responsibilities
- 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
Basic Qualifications
Master’s and 3+ years of medical/regulatory writing experience
OR
Bachelor’s and 5+ years of medical/regulatory writing experience
OR
Associate and 7+ years of medical/regulatory writing experience
OR
High School Diploma/GED and 9+ years of medical/regulatory writing experience
Preferred Qualifications
- Advanced degree in life sciences
- Thorough scientific background in cellular immunology or related field, or oncology
- Experience with generating text from data or literature
- Experience with clinical trial-related report documents
- Demonstrated advanced writing skills with excellent command of English language and grammar
- Proficiency with MS Office Suite, EndNote, and MS Word 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 questions, and propose solutions
The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply.
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The salary range for this position is: $112,710.00 – $145,860.00. Gilead considers a variety of factors when determining base 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.
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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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ poster.
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