Global Program Manager - Filing

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Global Program Manager - Filing (fGPM), as a core member of cross-functional Global Filing Teams (GFT), drives development of the filing strategy, converts the strategy into a feasible plan, and facilitates its timely execution, resulting in a fit for purpose dossier that supports the intended label, leading to drug approval by Health Authorities worldwide.

The fGPM brings extensive project management and filing experience across molecules and therapeutic areas to the GFT, accelerates informed decision-making, leads effective ways of working, and catalyzes change.
 

The Opportunity

In this role, you will partner with Global Regulatory Leaders (GRLs) and Global Filing Team Leads (GFTLs) to guide and support Global Filing Teams.

Within the GFTs  we: 

• Actively drive filing strategy discussions and ensure alignment with multiple functions and stakeholders

• Assess complexity of the filing, identify potential risks, and guide teams in the development of mitigation activities

• Translate the filing strategy into tangible outcomes via effective project planning and creation of a high quality filing timeline with clearly defined activities, interdependencies, duration, task owners and planning assumptions

• Own and monitor execution of the project plan; collaborate closely with the GFTL and team members to prioritize and align team’s activity in support of the plan, and ensure the team focuses on the right work at the right time

• Drive the identification of opportunities to accelerate project execution and encourage teams to target ambitious timelines

• Effectively facilitate meetings, and document outcomes, decisions and action items, and ensure communication of filing status and issues to relevant GFT members, functions and stakeholders

• Champion team dynamics, monitor team health, and lead new ways of working with the aim to build a high-performing team 

• Provide coaching support and feedback to team and team members, and address conflicts and concerns that may arise within the GFT, functions, or with stakeholders

• Apply critical thinking and drive team to make informed decisions faster

• Collate data and metrics to evaluate and ensure continuous improvement of filing processes

• Determine when issues need to be escalated to upper management and initiate the process

Within the Filing GPM community and wider GPM function:

• Proactively contribute to the Filing GPM community by attending fGPM team meetings, sharing knowledge and experience, and helping others through coaching and mentoring, thereby increasing the collective performance of the group. 

• Lead and/or contribute to functional initiatives, or represent the department effectively on cross-functional teams, to contribute to the broader organization

Mindset:

• Exemplify the behaviors of focusing upon the right work, taking smart risks, speaking up and challenging, fostering learning and creativity, and collaborating and building networks  

• Seek to simplify and prioritize, act with urgency, act on behalf of the enterprise, lead with inclusion, build company reputation, exhibit a growth mindset, and build a culture of trust. 

Who you are

• Bachelor's Degree in Science required; advanced degree preferred.

• Successful candidates will have a minimum of 1-5 years of relevant drug experience in the pharma/biotech industry, including a minimum of 1-3 years supporting cross-functional teams in a scientific environment.
  Strategic and analytical thinking to assimilate complex information to inform decisions.

• Strategic leadership and influence to be effective in a highly matrixed organization with geographically dispersed teams.

• Operate effectively in situations of ambiguity and guide teams through challenges, simplifying/distilling complex issues and influencing change in a skillful and mindful way.

• Demonstrated contributions to functional and/or cross-functional initiatives.

• Anticipate th