Lifecycle Portfolio Management - Annual Reports (Budapest)

Lifecycle Portfolio Management - Annual Reports (Budapest)
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Sanofi is a global pharmaceutical leader providing healthcare solutions in more than 170 countries around the world. Sanofi has over 100 000 employees representing 145 nationalities worldwide.

Sanofi aims to create a workplace culture, which results in employee fulfillment and contributes to making our value proposition a global reality. We are proud to have received the Top Employer Institute’s official recognition for the third time as well as the Top Employer 2021 qualification, both in Hungary and globally.

The core purpose of Sanofi Business Services is to drive transformation and digitalization to enable best in class service delivery. Together we are to create value - we facilitate the work of business divisions to focus on their core competencies so that Sanofi can provide the best healthcare possible. Every day, you will experience what it means to make a strong contribution to the transformation journey which will empower the life of our patients. We offer the best in class benefits, and the opportunity to develop your own career whilst ensuring a healthy work-life balance.

The offices of Sanofi Business Services are in Váci Greens, in the heart of one of Budapest’s most famous business districts. The site offers a comfortable, sustainable and friendly working environment with community areas, gardens and bicycle storage. It is easily accessible by transportation; the site is between Gyöngyösi utca and Forgách utca metro stations.

If you want to join a purpose driven company that has empowering life of patients as its core, then explore our opportunities in Sanofi Business Services!

THIS IS OUR SANOFI. DISCOVER YOURS.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Lifecycle Portfolio Management - Annual Reports

KEY ACCOUNTABILITIES:

  • Coordination and tracking of annual report activities, maintaining schedule of annual report requirements for all products, based on local and international regulatory requirements and interfacing with appropriate functions.
  • Responsible for collecting key information for the products that are overlapping with acquired companies’ portfolios.
  • Participate to the preparation / update of quality documents and training materials pertaining to Annual Report activities.
  • Participation to the development / improvement of tools and processes used for the management of the Annual Reports activities (Sharepoint, Vault RIM, reporting tools)
  • Present data and information to key leaders / stakeholders for decision making and action.
  • Closely interact with colleagues in quality, performance and business process/operational excellence roles to ensure optimal processes and tools are developed and implemented.
  • Perform KPI analysis and compliance analysis (CAPA analysis).
  • Strong understanding of global regulatory requirements, submission processes and the drug development process.
  • Experience in planning, coordinating and managing different stages of submission development.
  • Maintain independent abilities to learn quickly and adapt to new technologies/environments.
  • Self-starter, who motivates and negotiates with an agile and positive approach.
  • Demonstrated leadership ability, with strong negotiating and influencing skills.
  • Ability to lead complex projects and timelines in a matrix team environment.
  • Ability to identify critical issues and understand complex issues and propose creative and achievable solutions through using appropriate information. Determines the causes and possible solutions to the problem.
  • Strong attention to detail and accuracy.
  • Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.
  • Ability to cultivate internal and external relationships.
  • Applicable knowledge of the drug development process.
  • Proficiency working in eCTD publishing tools, RIM systems, MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.

REQUIREMENTS:

  • Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience
  • 3+ years of experience in the pharmaceutical industry or equivalent.
  • High degree of knowledge regarding compliance and regulations.
  • Working knowledge of drug laws, regulations and guidelines is essential.
  • Strong command of the English language, both spoken and written.
  • Potential for some domestic and/or international travel
  • Ability to operate with agility in a dynamic global environment
  • Ability to maintain discretion and confidentiality about sensitive data
  • Ability to communicate and collaborate on many levels, including issue escalation to GRA leadership.

 

Budapest

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