Disclosures and Transparency Manager
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 Manger Disclosures and Transparency.
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.
The successful candidate for Manager Disclosures and Transparency, will be based in the Dublin Central Office which is Gilead's newest European office. The Dublin Central office will be a Centre for Paediatric Excellence and will allow for cross-functional interaction.Essential Functions:
Knowledge, Experience & Skills:Essential:
- Partners with and leads interactions with other functional areas and demonstrates an ability to effectively collaborate cross-functionally
- Manage registration of new protocols, maintenance of protocol records, and results postings
- Participates in redaction of clinical trial documents for EMA Policy 0070 and generation of redaction justification tables
- Acts as an advisor to various groups on appropriate strategies for disclosure activities
- Demonstrates exceptional operational and organisational skills to ensure disclosure and transparency activities are performed on time and with the highest of standards
- Evaluates evolving regulations and public guidance on clinical trial disclosure and data transparency to maintain Gilead compliance
- Manage clinical trial disclosure activities and participates in and/or authors new protocol registrations/registration updates and results postings for release on clinical trial registries
- Participates in redaction of clinical trial documents and generation of redaction justification tables required for Policy/0070.
- Works effectively within an evolving and dynamic environment and has a proven track record to quickly adapt to changing regulations, processes, priorities, and deadlines.
- Proven ability to anticipate and identify areas of change, assess potential impact, propose strategic adaptability, and lead and oversee change management efforts.
- Have excellent verbal and written communication skills and interpersonal skills. Shows flexibility in communication style to work effectively in a team environment.
- Ability to build productive working relationships internally and externally.
Equal Employment Opportunity (EEO)
- A B.Sc. degree
- Considerable relevant clinical development or regulatory affairs experience in the pharmaceutical/biotechnology development environment (e.g. Sponsor or Clinical Research Organization (CRO))
- Preferably direct experience in disclosure and/or data transparency, clinical operations or medical writing/clinical submissions.
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/Disclosures-and-Transparency-Manager_R0018984
Copyright 2017 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency