R&D TMF Support Team Lead

Job title: R&D TMF Support Team Lead

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Location: Hyderabad

About the Position

We are looking for a dynamic leader to manage our TMF Support team within the Hyderabad Hub. This role focuses on delivering high-quality outcomes and advancing excellence across all related functions. The ideal candidate will be enthusiastic about people development and adept at fostering robust relationships with global functional leads. Core accountabilities include overseeing inspection-readiness activities for Sanofi electronic Trial Master File (eTMF) system, including QC and migration of TMF records. The successful candidate will play a crucial role in ensuring compliance, efficiency, and best-in-class service delivery within our global operations.

Main responsibilities include:

• Lead and manage the TMF support team and activities in the Hub, with commitment to delivering high quality results and overcoming challenges with successful execution.

• Collaborate with global functional leads and teams on business topics such as metrics, prioritization, and performance.

• Foster employee development to build subject matter expertise and encourage collaboration with global functions to enhance knowledge sharing and drive process improvements.

• Promote teamwork, quality, operational efficiency, and innovation. 

• Ensure team activities compliance with health authority requirements, Sanofi SOPs, and departmental standards.

• Stay updated on evolving TMF Support practices, and inspection readiness requirements to maintain industry leadership.

• Foster a change-agile environment and function as key change agent for new processes and technologies.

• Manage budgets and oversee initiatives to support legal requests, mergers, audits, inspections, and other organizational needs.

• Provide mentorship to staff, manage hiring and training processes, and ensure performance goals are met effectively.

• Knowledge of drug development, regulatory or other guidelines pertaining to document standards and retention requirements. Knowledge of electronic document management systems.

• Strong leadership ability coupled with strategic and innovative thinking.

• Proven ability to manage changes, negotiate and influence others, and resolve conflict.

• Understanding of business considerations (basic finance, human resources).

• Ability to adapt to needs of an evolving business environment (e.g., regulatory requirements, corporate structure and processes, customer focus, technological advances,).

• Management skills including, but not limited to leadership, prioritization, team inspiration, cross-cultural sensitivity, delegation, empowerment, and accountability.

• Fluency in English (written and spoken).

About you

• At least a bachelor’s degree, or equivalent, in life sciences, or related areas of study, and relevant experience.

• At least 3-5 years of industry experience, including building and leading teams, even in a matrix environment.

• Working knowledge of drug laws, regulations, and guidelines.

• Ability to work across time zones and cultures.

• Organizational and process change management experience.

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, gender identity or Veteran status.

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!