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Transversal Study Information Implementation Lead

date posted 09/10/2022
contract type Full time
job id R2649848
location Gentilly;

POSITION OVERVIEW:

The Transversal Study Information Implementation Lead (Implementation Leader) will build, tailor, and execute the specific operational strategies, programs, and initiatives to supportthe complete identification, tracking and internal communication of organized collection and analytics of human data whereby Sanofi can have international, regional or local obligations or commitments.

KEY RESPONSIBILITIES:

The Implementation Leader will act as a constructive member in the global core team of Global Transversal Operational Governance, monitoring and assessing data entry and quality strategies for current systems as well as for future assets.

  • Establish, maintain and strengthen partnerships with critical internal stakeholders such as Clinical, Pharmacovigilance, Transparency, Real World Evidence, Ethics and Business Integrity, Medical Affairs and more to support the implementation of the Quality Standard and Operating Procedures at global, regional and local level and develop an internal understanding of their expectations

  • Develop and implement strategies supporting the long-term and the short-term business objectives for the continuous improvement of data entry and extraction methods.

  • Support future expected system changes to align with the Company and Standard strategy

  • Collaborate with key internal cross functional shareholders to shape policies

  • Assess regulations on an ongoing basis to ensure reporting and disclosure obligations and commitments are adequately met for all types of studies.

Drive the adaptation and the implementation of Operational Governance strategies and plans in all functions through:

  • Oversight of systematic reference tracking solutions to ensure options reflect realities and utility of global tools

  • Establishing Key and/or Quality Performance Indicators to aid in oversight of risk trends

  • Interaction with key organizations and stakeholders as “the point of contact” to keep constant dialogue and flow of communication

  • Assessing the need for system evolution by endorsing control proposals in line with reporting expectations and ensure performance indicators are tracked/monitored to support business needs.

Strengthen the reputation and unique positioning of Sanofi in various reporting genres

  • Lead and Support policy shaping projects based on identified trends or risks for regulatory, safety, and public disclosure reporting in particular

REQUIRED EDUCATIONAL BACKGROUND AND JOB-RELATED EXPERIENCE:

  • A minimum of 10 years (combined)of professional experience in study management, regulatory/safety reporting, project management or other relevant experience in the pharmaceutical industry.

  • Bachelor’s Degree (accredited four-year College or university) is required.

  • ​Scientific background, knowledge/experience in study management desired.

  • This position will require strong collaboration across the Local and Global teams. Identified candidates will have proven experience in developing and leading within a highly matrixed environment.

  • Languages: Fluent English (oral & written)

LEADERSHIP SUCCESS PROFILES & COMPANY VALUES:

  • Excellent understanding of International regulatory and scientific environment.

  • Excellent knowledge of medical activities and related operations.

  • Strategic thinking.

  • Developed leadership including team motivation/strong sense of purpose, ability to problem-solve, prioritize, take initiatives and meet challenges.

  • Excellent communication skills.

  • Excellent organization, planning and project management skills.

  • Business and customer orientation.

  • Strong collaborative skills.

  • Ability to lead change and challenge status quo.

  • Ability to propose innovative and simple solutions.

  • Results oriented

  • Cooperate transversally across business units and with external customers

  • Exceptional attention to compliance

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. 

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

#GD-SA
#LI-SA

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.

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