Senior Associate, Regulatory Operations

Location
Foster City
Salary
See job description.
Posted
May 08 2021
Ref
R0018946
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager


Senior Associate, Regulatory Operations
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


Job Overview:
  • As a member of the Regulatory Operations team, performs moderately complex to non-routine submission compilation and publishing activities associated with generating hard copy and electronic submissions.
  • Publishes and validates large and complex submissions with little supervision from a manager. Adopts responsibility for submission activities occurring under their guidance.
  • Routine and complex document formatting and report processing of all types with little supervision and involvement by manager.
  • Adopts responsibility for document processing activities occurring under their guidance.
  • Publish and Document format EU Pediatric submission documents and Great Britain regulatory submissions.


Job Responsibilities:
  • Prepares a variety of submissions including utilization of publishing tools for electronic and paper submission generation, scanning, QC, and electronic and paper archival in partnership with Central Records.
  • Performs filing and data retrieval functions as directed, or in conjunction with departmental SOPs.
  • Participates in supporting and promoting current electronic initiatives in moving the company forward with electronic submissions and electronic archives.
  • May interface with project managers, regulatory product managers, and or content authors to provide guidance on submission preparation and content.
  • May represent Regulatory Operations by taking the lead in submission planning meetings to help to become familiar with the submission priorities.
  • Performs workflows and procedures regarding document tracking, indexing, retrieving and disseminating of regulatory agency submissions as defined by Regulatory Operations management.
  • May assist and/or provide training to others on software tools used and educating authors on publishing policies and procedures.
  • Leads projects of high complexity. Makes independent and appropriate decisions. May lead cross-functional projects and represent Reg Ops at project meetings. Proactively communicates the status of ongoing projects and submissions to the manager and suggests solutions to problems.
  • Prepares a variety of routine and non-routine Word and PDF formatting including utilization of Document Processing supporting tools for submission-ready documentation.
  • Performs filing and data retrieval functions as directed, or in conjunction with departmental SOPs.
  • Participates in supporting and promoting current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
  • Interface with projects managers, regulatory product managers, and or content authors to discuss routine and non-routine documentation preparation and content.
  • May take significant responsibilities in submission planning meetings to become familiar with the submission priorities.
  • Performs workflows and procedures regarding document tracking, indexing, retrieving and disseminating of regulatory agency submissions as defined by Regulatory Operation management.
  • Carries out project tasks under the direction of manager. Provides the status of their ongoing projects and Document Processing activities to the manager when required.
  • Provide training to others on software tools used and educating authors on Document Processing procedures and submission-ready requirements.
  • Leads projects of high complexity. Makes independent and appropriate decisions. May lead cross-functional projects and represent Reg Ops at project meetings. Proactively communicates the status of ongoing projects and submissions to the manager and suggests solutions to problems.


Knowledge & Skills:
  • Demonstrates continued success leading projects with minimal supervision.
  • Demonstrates an ability to lead software implementation.
  • Demonstrates strong project management skills, with the ability to manage the tasks of more junior associates.
  • Demonstrates an in-depth knowledge of eCTD.
  • A consistent demonstration of attention to detail, timeliness, and accuracy is critical.
  • Demonstrates continued success leading involving regular Word and PDF formatting, with high-quality work output that requires minimal supervision.
  • Expert technical knowledge of current systems (Word, Acrobat, document management system, Document Processing supporting tools)
  • Demonstrates knowledge of how system implementations work.
  • Demonstrates strong project management skills, with the ability to manage the tasks of more junior associates.
  • Demonstrates a depth understanding of requirements for documentation sent to agencies by Gilead.
  • A consistent demonstration of attention to detail, timeliness, and accuracy is critical.


Education & Experience:
  • A good level of relevant experience and a BA, BS or MS
  • Relevant experience includes electronic document management systems, global regulatory submissions, or other experience directly related to Regulatory Operations.


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/Senior-Associate--Regulatory-Operations_R0018946-1





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