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Gilead Sciences, Inc. Manager – IC-GPS Publishing Regulatory Operations in Uxbridge, United Kingdom

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Founded in 1987 in Foster City, California, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 18,000 employees in offices across six continents. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

We have an exciting opportunity within our Regulatory Operations team for a Manager who will be responsible for the management of a growing, dynamic, and fast paced Regulatory Operations team.

With increasing speed, the countries covered by the IC-GPS team has changed from “developing” to “emerging” to “growth” markets. Our IC-GPS Regulatory Operations team supports submission activities for over 130 countries, spanning, Africa, Asia, Eastern Europe, EAEU, LATAM and Middle East, with a large variety of formats and requirements. Some have converted to eCTD format and with a variety of others moving towards implementation, this makes for a very dynamic and exciting environment with lots of opportunity for growth and development.

Job Overview / Summary

Based in either Cambridge or Stockley Park, this role will include the responsibilities of an established team under the oversight of a Senior Manager.

You will be managing associate level employees and this role will include but is not limited to, provision of guidance, coaching, development and performance management alongside planning and oversight of workload and resource. In addition, you will maintain oversight and interpretation of submission requirements and guidance in allocated regions and ensure we always maintain our high standards of submission.

This exciting management opportunity is both strategic and operational and as a member of the IC-GPS team, you will be performing, leading, and providing oversight for the publishing of major and or complex submissions, process development and RO systems.

You will also represent our team and / or department with external functions such as Regulatory Project Management, Regulatory Affairs, Regulatory Information Systems, affiliates and content authors to provide guidance on submission preparation and content.

Job Responsibilities

  • Responsibility for managing the IC-GPS Regulatory submission publishing team. Including provision of guidance, coaching, development and performance management alongside planning and oversight of workload and resource.

  • Perform and lead the preparation of major or complex submission compilation activities including utilization of publishing tools for electronic and paper submission generation, internal quality review and archival according to current health authority guidance, internal standards, and defined timelines.

  • Oversight of publishing tasks conducted by both internal staff as well as submission activity executed by outside vendors

  • Maintain oversight and understanding of the regulatory environment, procedures, intelligence, and submission standards. Providing guidance and interpretation of submission requirements for allocated regions.

  • Provides functional and technical guidance and or training to junior colleagues in the Regulatory Operations.

  • Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content and representing Regulatory Operations by taking the lead in submission planning meetings to help define company submission priorities.

  • Guides more junior colleagues on working with project managers, regulatory product managers, and or content authors to provide guidance on submission preparation and content.

  • In addition to submission compilation activities, may lead and /or contribute with the development and management of projects and initiatives as applicable in support of Regulatory Operations.

  • Maintains constructive and positive interactions with colleagues.

  • Be a subject matter expert for IC-GPS submissions. Provide cross-functional education to partners in RA, CMC.

  • Be a key member of the Global Regulatory Operations Leadership team, helping to identify, propose, develop, and manage improvement projects that align with Gilead’s global working philosophy.

Knowledge & Skills

  • Successful candidates will be degree educated and have significant experience within a Regulatory Operations publishing environment.

  • This role requires expert knowledge of submission publishing tools and systems, Microsoft Word, Adobe Acrobat and Document Management Systems.

  • Demonstrates an in-depth knowledge of eCTD.

  • Demonstrates people management skills and experience and a desire to manage the performance of more junior level individuals.

  • Strategic thinking is required, with a focus on process improvement and optimization.

  • Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.

  • Candidates will demonstrate an ability to balance multiple tasks to achieve goals, to meet deadlines and customers’ expectations.

  • The ideal candidate will align with Gilead’s core values by being inclusive, accountable for their work, displaying integrity in everything they do, thriving in a team environment, and seeing excellence as the only measure of success.

  • Demonstrates strong project management skills, with the ability to manage the tasks of more junior associates.

  • Demonstrates an ability to effectively communicate cross-functionally.

Education & Experience

  • Significant relevant experience and / or a BA, BS or MS.

  • Experience in regulatory submission publishing is required.

  • Regulatory Operations experience in numerous geographic regions is desirable

  • Leadership experience required

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 (!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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. T he health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.