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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.

Job Description

FUNCTION: Labelling, Artwork & Translations (LAT) - Regulatory

FUNCTION OVERVIEW:

Labeling Artwork and Translations (LAT) is a core function within Gilead's Global Regulatory Operations organization and acts as a critical strategic partner across cross-functional teams. LAT manages, updates, and maintains product information labeling and associated documentation, including translation and artwork for all Gilead products in applicable markets outside of the U.S., China, and Japan. This includes managing and coordinating language translations of product information labeling and associated documentation and supporting development and maintenance of artwork through strong collaborative partnerships, as well as maintaining relevant processes and considering process improvements, to allow efficient and compliant work. LAT plays a key role in ensuring product information labeling and associated documentation is fully compliant with governing laws, regulations, and company policies and procedures, while being aligned with business goals and objectives, to facilitate effective review by health authorities and other stakeholders, as well as to avoid errors in product information labeling to protect patient safety.

LAT works closely with cross-functional partners to ensure timely and appropriate delivery of product information labeling translations and artwork updates, including other Regulatory and Development teams, Legal, Commercial, and external third parties i.e., translation vendor and regulatory agencies.

POSITION OVERVIEW:

You will be responsible for contributing to the definition, development, and implementation of process improvements and initiatives to meet the evolving needs of the LAT group. You will represent LAT on a broad array of cross-functional teams, meetings and communications. You will act as the main point of contact for the Regulatory Translation Vendor, developing and managing the relationship through day-to-day interactions as well as leading simplification and improvement initiatives, as applicable. You will take the lead on operational translation and artwork activities involved in label preparation, as required, in line with regulatory authority requirements, industry standards and company policies and procedures. You will maintain awareness of regulatory intelligence and guidance, as this impacts product labeling, artwork, and translations, and educate internal/external partners on these matters and their evolution. You will be responsible for training and advising new or less experienced colleagues, as well as cross-functional partners, in various LAT policies, practices, processes, systems, and other tools. You will be responsible for raising, informing, and resolving any issues that may impact labelling, translation, and artwork activities, including submission process or timelines, working with all applicable parties. You will support inspection-readiness activities when applicable.

JOB SKILLS/REQUIREMENTS:

• Effective project management skills and planning strategies, strong analytical thinking and problem-solving skills.

• Decision-making skills, with the ability to develop solutions to a wide range of complex problems which require the regular use of ingenuity, creativity, and innovation, ensuring solutions are consistent with organization objectives.

• Excellent verbal and written communication skills; participates actively in meetings, has ability to provide direction to a team, and to negotiate with and influence various stakeholders.

• Strong technical or analytical knowledge base, with ability to assess data, processes and understand the regulatory or process implications.

• Ability to research and interpret new regulatory requirements relating to LAT areas of expertise, make recommendations based on impact to existing processes and oversee implementation.

• Ability to be flexible and adaptable to change, a fast learner, and to move between projects easily and provide support/expertise where needed.

• Excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines.

• Has an appropriate level of IT skills in Microsoft Excel, PowerPoint and Word. Familiarity with other tracking or business intelligence tools will be an advantage.

• Knowledge of the role of regulatory affairs in achieving cross-functional drug discovery, development, and commercial goals and objectives, as well as working knowledge of labeling, artwork, and translations regulations and guidance is preferred.

• Working knowledge of technical aspects associated with labeling and artwork, such as electronic systems is preferred.

• When needed, ability to travel.

Education & Experience

BA/ BS or advanced degree in life sciences or related field with significant regulatory or related experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Prescription drug labeling or related work experience.

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 log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.