Project Manager (e-labelling program)

Posted Yesterday
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Hyderabad, Telangana
Mid level
Healthtech
The Role
As a Project Manager for the e-labelling program, you will engage stakeholders, coordinate ePI updates, submit dossiers for Health Authorities, liaise with affiliates for translation, and ensure quality control and compliance with local regulations.
Summary Generated by Built In

Job title: Project Manager (e-labelling program)

  • Location: Hyderabad
  • % of travel expected: 15%
  • Job type: Permanent

About the job

Our Team:

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data products to increase reusability & interoperability and thus accelerate impact on global health.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support global project management from the hubs.

Main responsibilities:

•          Ensure strong stakeholders’ engagement (Global and Local Regulatory teams, Affiliates, Business…) and steer the different ePI updates all along the process

•          Ensure alignment on content (leaflet only, instructions for use, other educational material …)

•          Dossier submission: To prepare ePI related part for Health Authorities Dossier submission, in relation with local regulatory Teams

•          Liaise with affiliates - To collect page content translation, to reprocess approved local PI

•          Create and Master planning to support implementation activities on epi site, to support the team with creation of templates…

•          Quality Control - To ensure formal validation before any publication

•          Global and Local maintenance - To orchestrate necessary content update (Local regulation request, product request…)

•          Website content structuration - To organize strategic meetings with the regulatory, marketing, labelling, and medical departments to define the content of the ePI pages before the launch

About you

  • Experience:
    • Master’s degree in Life Sciences or business operation
    • Experience in the Biological, chemical or pharmaceutical industry (3-5 years) is a plus
    • Demonstrated ability to drive initiatives from concept to execution
    • Good functional knowledge on industrial business processes is a plus
  • Skills:
    • Regulatory background & capability to interact with (internal) Regulatory Teams and ability to understand local regulation and compliance
    • Strong project drive & coordination skills
    • Effective work in a matrix organization
    • Great communications, organizational, planning and presentation skills
    • Engages and leverages everyone’s strengths while being highly self-aware
    • Strong analytical skills. Decision making by analyzing current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focused on priorities
    • High level of autonomy. Executes, is comfortable with ambiguity, ​and adapts with agility. Takes calculated risks and anticipates potential issues.
    • Inspires trust through empathy and authenticity. Empowers and recognizes others to create powerful relationships and networks.
    • Encourages the teams to stretch and do things differently
    • Sets a clear context and creates space for the teams to take action.
    • Makes sure the teams understands how to act for patients and customers.
    • Approaches the role with humility and thinks Sanofi first.
    • Act for Change : ability to shape a technological / operations vision, influence and engage leadership and project team.
    • Strive for Results: stretched ambition and take action
    • Cooperate transversally / ability to manage ambiguity and partners without solid reporting lines
    • Commit to Patients and full product quality
  • Languages:
    • Fluent English

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, 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!

The Company
HQ: Paris
85,000 Employees
On-site Workplace
Year Founded: 1973

What We Do

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.

Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms

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