Sanofi Group Trial Operations Medical Affairs Process Governance & Training Expert in Bridgewater, New Jersey

Trial Operations Global Medical Affairs Processes Governance and Training Expert

The Trial Operations Global Medical Affairs Processes Governance and Training Expert works in close collaboration with the Late Phase & Real World (LP&RW) and the Trial Operations Transversal Experts teams to propose, develop or improve processes in a centralized and consistent manner for the benefit of the performance and productivity of the LP&RW Trial Operations activities.

This role is involved in global harmonization and optimization of operational processes with R&D Team and fosters innovation and continuous improvement. Also responsible of the LP&RW governance of all transverse initiatives involving a LP&RW member and is leading some of the working groups according to prioritization given by the LP&RW Group Leader. Will represent Trial Operations (TO) LP&RW in some of these working groups within TO, CSO or with other departments. Central point of contact for all process related matters to ensure consistency across various transversal initiatives. This individual is the main point of contact for Q&CI for all topics related to Quality documents development and roll-out, process and questions. They will centralize training and general awareness material on Late Phase specificities and ensure availability of the material within the TO organization and within CSO as applicable. He/she develops part of this material by interfacing on a regular basis with the LP&RW team members and others stakeholders as relevant. Dispense training to new comers and others as relevant. Will also be a member of the Extended Steering Committee.

Responsibilities

  • Global harmonization and optimization of operational processes with R&D Team and fosters innovation and continuous improvement

  • Develop or improve processes in a centralized and consistent manner for the benefit of the performance and productivity of the LP&RW Trial Operations activities.

  • Key contact for Q&CI for process questions related or QD development at concept stage or for revision: centralize the review of QDs by SMEs and/or review him/herself

  • Responsible for the LP&RW governance of all transverse initiatives involving a LP&RW member in close collaboration with the Champions network in LP&RW when available (and except IVRS, Central lab).

  • Lead selected working group(s).

  • Represent TO LP&RW in some working groups.

  • Build appropriate interfaces with other departments and participates in cross departmental working groups for process development optimization

  • Facilitate a consistent implementation of quality processes within Trial Operations LP&RW: Develop and maintain training material for new comers in the field, provide training or organize training sessions for new comers, is member of the Training curriculum review team to define learn certification for LP&RW team members and analyze impact of new QD/processes to the LP&RW team and share information widely.

  • Training: Develop and maintain training material for new comers in the field and provide training and organize training sessions for new comers

  • Contribute to the development of the awareness on Medical Affairs specificities within and outside Trial Operations

  • Outsourcing: Part of the Outsourcing Breaking News (OBN) committee for the operational implementation of outsourcing strategy and contributes as relevant to the implementation of operating model with preferred partners/CROs in collaboration with LP&RW Group Leader, LP&RW DM Champion and other key stakeholders.

Required Education/Experience

  • Pharm D, or equivalent (Bachelor’s degree +5 or 6), or Master’s degree in Biology, Information Sciences or scientific related field with at least 10 years’ experience in Pharmaceutical Industry.

  • Previous experience of at least 5 years in Clinical Development.

  • Knowledgeable of clinical processes and systems regulatory/quality compliance requirements including in the post-marketing area.

  • Successful experience in leading and managing large and global projects including transversal projects

  • Leadership and Project Management skills

  • Experience collaborating with project teams, departmental associates, internal and external partners

  • Organizational, interpersonal and communication skills (verbal and written); flexibility, diplomacy, efficient in matrix organization and transverse management.

  • Self-motivation, attention to detail while overseeing and connecting with cooperating departments

  • Results-driven in terms of timelines and quality.

  • Customer & quality focused.

  • Very good presentations and training skills.

  • Experienced and knowledgeable of International regulatory and scientific environment in Clinical Development and post-marketing environment.

  • Competent in International Regulations /Guidelines/Good Practices (GCP and GPP) pertaining to the pharmaceutical industry standards and practices.

Preferred Experience

  • Green belt certificate

  • Training, mentoring/coaching/tutoring

Sanofi US Services, 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.

#LI-SA

#GD-SA

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.