Lead the development of protocols and amendments for CSD (Medical Writing) in the Oncology therapeutic area, including development and management of timelines and resource planning, supporting large clinical programs.
Oversee internal and external medical writers on protocols and amendments to ensure the highest quality of medical writing and adherence to Gilead content and quality standards.
Independently author a wide variety of clinical/regulatory documents such as protocols and amendments, ICFs, CSRs (all phases), and IBs according to regulatory requirements and internal Gilead document standards.
Author high complexity documents such as integrated CTD summaries/overviews, PSPs, PIPs/PIP modifications, or regulatory responses with some input from a more senior CSD team member.
Participate in development/improvement of document standards, templates, and processes and other non-medical writing activities.
Excellent verbal communication skills. Can effectively communicate with a variety of teams and individuals.
May coach, train, and provide mentoring and guidance to less experienced writers.
Requirements
Bachelor's Degree and Eight Years' Experience
OR
Masters' Degree and Six Years' Experience
Ph.D.
PharmD/PhD with 4+ years' relevant experience.
MA/MS/MPH/MBA 6+ years' relevant experience.
BA/BS with 8+ years' relevant experience.
Significant content strategy and development, regulatory, quality, clinical R&D, or related experience supporting medicinal products.
Significant experience in the biopharma industry is strongly preferred.
Experience authoring a broad range of regulatory, scientific, medical and other business content across multiple stages of drug development.
Knowledge of AI and other emerging technologies to complete medical writing or related deliverables is preferred.
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, Adobe, Excel, and the Regulatory Document Management System.
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, aspira
Benefits
Health insurance
Additional Information
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
Gilead Regulatory Affairs is a committed and proud team of highly skilled professionals dedicated to helping deliver therapies in the most efficient and effective way to patients with unmet medical need around the world. We bring our passion for science, discovery, and innovative strategic thinking into everything we do. The Content Strategy & Development (CSD) department is part of Innovation, Content, & Execution (ICX) within Regulatory Affairs, and advances the strategy and creation of high-quality documents to support efficient and successful regulatory submissions.
We are an inclusive and diverse community, supported by strong leaders who are committed to providing individual development and growth opportunities while achieving our mission. Our collaborative and supportive structure help support work-life balance.
Gilead Sciences · - California - Foster City