Quality Review Specialist

Location
Dublin 2
Salary
See job description.
Posted
May 08 2021
Ref
R0019434
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager


Quality Review Specialist
Ireland - Dublin

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


The impossible is not impossible.

It's simply what hasn't been achieved yet.

Creating Possible drives everything we do. It's evident in our mission and core values. This is how we built a culture of excellence that is fuelled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases.

We are looking for a unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for someone who is passionate about data accuracy to join a Gilead as a Quality Review Specialist. You will play a part in quality reviewing regulatory documents before submission to ensure data accuracy and appropriate content, style and messaging is presented to Health Authorities.

As part of the Regulatory Documentation and Submission Global team you will be given opportunities to grow as a quality professional, and quickly expand your knowledge and experience through the diverse range of activities. Each role within the team is highly visible and has a direct impact on helping to meet the company's goal of bringing transformative medicines to patients.

ESSENTIAL DUTIES AND RESPONSIBILITIES include but are not restricted to the following:

  • Perform high-quality reviews of regulatory deliverables

  • Function as the RDS Quality Lead for various regulatory deliverables

  • Assist in audit preparation

  • Support RDS Quality initiatives

  • Act as a departmental RDS Quality resource

    CORE COMPETENCIES

  • Performs detailed and thorough quality reviews to ensure data integrity, internal content consistency, completeness on a wide range of regulatory deliverables (CSRs, IB/Updates, CTDs, PK/Pop PK reports, etc) in accordance with Gilead RDS Quality standards and tools.

  • Performs editorial reviews to ensure style is consistent with the R & D Manual of Style and within regulatory deliverable.

  • Serves at the primary RDS Quality point-of-contact for assigned deliverables, monitors timelines, communicates with Lead Writer to ensure review expectations are understood and met, and alerts Lead Writer in a timely manner if deliverable is at risk.

  • Participates in RDS Quality team meetings presenting timelines and updates of assigned deliverables alerting team of any potential resourcing issues.

    Advises on deliverable review strategies.

  • Able to forecast individual project workload and proactively identify and communicate potential workload peaks.

  • Closely collaborates with Audit SME and Lead Writer to support audit preparation by gathering documents and performing quality review to ensure audit package is complete and accurate.

  • Assists with the development and delivery of relevant training and new hire onboarding programs.

  • Participates in development and/or revision of internal policies and procedures impacting quality standards and tools.

  • Contributes to the development and maintenance of applicable standard operating procedures, manuals, and work practices.

  • Responds to general Quality questions, helps train writers on review process and expectations, and remains current with Gilead and industry Quality standards.

    EDUCATION and/or EXPERIENCE REQUIRED

  • BS Degree or PHD in Life Sciences preferred

    Ability to work independently on basic job duties and understands criticality and time expectations of assigned activities and prioritizes as appropriate.

  • Ideally some relevant experience in a medical writing/clinical submissions environment preparing documents for regulatory submissions.

  • Ideal candidates include those who are familiar with Phase 1 to 3 clinical protocols and study reports and understand the drug development process leading to marketing applications

    Has developed organizational skills; is detail oriented; and able to work in a fast paced, deadline-driven environment.

  • Displays flexible thinking and willingness to adapt to changing approaches based on project needs and expectations.

  • Data driven who has an eye for detail

    Has excellent verbal and written communication skills and interpersonal skills- Can effectively communicate with a variety of teams and individuals, including team leadership and members of senior management.

  • Is capable of using advanced functions of various software applications, particularly the Microsoft Office Suite, Adobe Acrobat, and a Regulatory Document Management System.

    LOCATION

    Dublin

    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 to apply for this job.


    To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Ireland---Dublin/Quality-Review-Specialist_R0019434-1





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