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 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.

Specific Education & Experience Requirements:

- BA/BSc or MA/MSc and extensive writing experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions.

- Knowledgeable of regulatory document requirements/guidelines with direct experience in a wide variety of regulatory document types, including pediatric documents.

- Well-developed computer skills including proficiency in Word, Adobe, Excel, and regulatory document management systems.

Job Overview/Responsibilities:

We have an exciting and unique opportunity for a regulatory medical writer to join our dynamic team at the Associate Director level in Dublin, Ireland. The Dublin Pediatric Centre of Excellence plays a critical role in adapting innovative therapies to the pediatric population. You will prepare clinical documentation to support global pediatric regulatory submissions. You will have the opportunity to develop expertise in the preparation of a wide range of pediatric documents, particularly at the individual study report and submission level. You will work collaboratively within cross-functional pediatric teams (e.g., Regulatory Affairs, Clinical Development, Patient Safety, Biostatistics, Clinical Operations) to deliver documents on time and per team expectations.

Key responsibilities include:

- 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.

- Participates in cross-functional submission teams, or other teams, and provides guidance on regulatory submission document strategies. Provides advice on content strategy and optimal presentation of data for achievement of document objectives.

- Leads document timeline/resource planning for pediatric projects and submissions. As necessary, develops and manages timelines across multiple documents. May serve as lead medical writer and department representative on a pediatric submission or development program.

- Participates 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, including team leadership and members of senior management staff.

- May coach, train, and provide mentoring and guidance to less experienced writers.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Associate Director, Content Strategy & Development (Medical Writing)

Job Description