Associate Director, Medical Writing

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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
 

Job Description

Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. Medical Writing participates in cross-functional drug discovery, development and commercial product lifecycle management and contributes strategic, expert input into scientific and regulatory content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance Gilead's product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas (TAs) and in all markets around the world. 

We have an exciting and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory documents independently, including novel or atypical documents which require ingenuity and considerable medical writing expertise and autonomy. You will define the Medical Writing strategy, plans, and objectives for assigned products or projects. You will represent Medical Writing on relevant product, project, and/or regulatory submissions teams; providing specialist guidance on the optimal content and presentation of content to achieve product/project objectives. You may also represent Medical Writing on other cross-functional initiatives. You may serve as the filing lead for large complex regulatory submissions and as lead medical writer for a large development program or TA. You will participate in or may lead Medical Writing and cross-functional process improvement initiatives on regulatory document standards, template development, and document process. You may manage or supervise direct reports and contractors, overseeing recruitment and on-boarding.

EXAMPLE RESPONSIBILITIES:

• Authors a wide variety of documents of all types and complexities, such as clinical study reports (CSRs) (all phases), investigator’s brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses.

• Typically represents Medical Writing and participates in multiple cross-functional teams, such as regulatory submissions and/or other regulatory project teams and provides guidance on regulatory submission document strategies.

• Plans and oversees all assigned deliverables. May serve as a filing lead for large complex regulatory submissions, with responsibilities including development and management of document timelines and resource planning for assigned projects.

• May serve as a senior medical writer and department representative for a large development program or TA, including providing guidance to less experienced Medical Writing colleagues or contr