About the job

Our Team:

Sanofi Global Hub (SGH) is an internal Sanofi resource organization based in Budapest and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. SGH strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally.

 

 

Main Responsibilities: 

Support BIMO (Bio research Monitoring plan) compliance requirements through the production of “covered” clinical trial financial data to disclose, with a strong focus on FDA 21CFR54 (Food and Drug Administration)

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Responsible for ensuring that data is accurate, auditable, and aligned with External Regulatory Agency inspections

Collaborate closely with the global P2P team to review and consolidate costs to be disclosed in line with compliance and reporting needs of clinical trial submission to FDA

Collect, standardize, and structure data from multiple systems to ensure alignment with BIMO and other regulatory requirements

Identify automation opportunities within data management processes and support their implementation to improve operational efficiency

Monitor and manage deadlines in a global setting, working closely with relevant business partners to ensure timely delivery, within Projects type activities

Act as a point of contact for various business partners, providing support on data related queries and reporting tasks in a proactive and solution-oriented manner

 

Participation in special project of Inclusion of BIMO within Sanofi Operating Model (24 months +/-)

About you

 

Experience:

5+ years of professional experience in the event planning/contracting field, preferably in a highly regulated market.

Clinical Development Operations experience or knowledge/background is a plus

Direct experience in the pharmaceuticals and life sciences space is desirable.

Meeting planning and project management experience is an advantage.

 

Soft skills:

Ability to read legal documents and determine/communicate impact on business.

Strong critical thinking skills

Strong communication skills, both verbal and written

Ability to forge and maintain cross-functional relationships.

Ability to work independently to drive problem solving and process improvement.

Ability to collaborate effectively and work across multiple areas, when members of the work team are not direct reports.

Ability to influence stakeholders without authority.

Comfortable and capable in front of any group and discuss or present the project.

Ability to think strategically and provide insights on opportunities and impacts for the business.

Ability to identify and work with different business stakeholders to collaborate effectively and work across multiple areas to drive completion of requirements by state mandated deadlines.

 

 

Technical skills:

Excel – complex spread sheet development, maintenance and automation 

Strong Power Point skills with ability to present relevant content in a concise, visually clear format.

Strong data analytic skills, including preforming quality reviews.

Knowledge of Power BI, Qlik Sense is plus

 

 

Education: Advanced degree in areas such as Management, Statistics, Decision Sciences, Engineering, Life Sciences, Business Analytics or related field (e.g., PhD , MBA , Masters)

 

 

Languages: Excellent knowledge in English and strong communication skills – written and spoken.

Pursue progress, discover extraordinary

 

 

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!