Sanofi Jobs

A new perspective. A new challenge. A new opportunity.

Job Information

Sanofi Group Technology Operations and System User Experience Lead in Bridgewater, New Jersey

Job Description:

Collaborate with ITS to develop regulatory systems support strategy for GRA owned and administered systems , user administration, periodic review of accounts, interact with user community in a support model role, ensure efficient maintenance and administration of all GRA systems. The Application Support Users (ASU), that are a key component of the GRA Solution support model, will report into this group.

Duties & Responsibilities

Primary areas of responsibility include:

  • Provide leadership and guidance on business support topics Incumbent will work with autonomy and authority, while at the same time, respecting the organization structure, the domain knowledge and responsibilities of others.

  • Primary point of contact for the Business User Support group.

  • Lead the Business User support group. Ensure that the team is operating in a harmonized and efficient manner with respect to operations of the Business User Support function.

  • Provide operational direction to the team

  • Analyze the operational activities of the team and define the corrective actions needed to ensure operational excellence (define processes, metrics, remediate technical gaps that currently exist) and lead a global, multidisciplinary team to determine and implement enhancements. Define and establish metrics to operate in a mode of continuous improvement to ensure that GRA is meeting the needs of the users, including, internal as well as external clients

  • Collaborate with ITS, GRA Quality, Business Process and Operational Excellence and GRO Business Services to define Key Performance Indicators (KPI)

  • Ensure adherence to KPIs and corresponding reporting and escalation, if KPIs are not met

  • Establish goals of vendors/contractors associated with the Business Support role

  • Manage resource objective setting, assignment and performance appraisal for internal resources

  • Manage the Business Support staff to ensure productivity and efficient use of resources

  • Identify and alert management of potential issues and project conflicts. Drive to identify and resolve issues to ensure timely and accurate resolution of problem tickets

  • Maintain awareness of system operation, configurations and business requirements

  • Ensure team training curriculum is established and communicated to appropriate stakeholders

  • Ensure team members are compliant with Training requirements

  • Develop and maintain reference material for end-users such as FAQ lists, web-site material, and newsletters pertaining to Registration Data

  • Collaborate with GRO Change Management and Training group to ensure that Users are kept aware of changes to the system and know where to find reference material. Provide input to the team to Investigate and implement new training methodologies and/or modules to leverage of any new training tools to improve the effectiveness of required training

  • Consult with users on document security, roles, groups, and document permissions.

  • Resolve end-user questions/problems and troubleshoot issues

  • Suggest and make changes to security matrix, coordinate, and disseminate change information to document management and/or ITS groups

  • Brainstorm and propose solutions to address non-standard queries and problems.

  • Maintain proficiency with advanced tools (eg, batch import/export)

  • Support the implementation of the targeted solution

  • Participate in System Implementation Projects

  • Provide input to the creation of quality documents, namely SOPs and WINs, , user guides, job aids, etc. and assume ownership as appropriate

  • Timely, accurate and succinct communications to appropriate stakeholders regarding support topics

  • Identify customers and band them, as appropriate, for purposed of messaging on business support topics

  • Craft appropriate messages regarding business support, keeping target population in mind

  • Provide input to ITS colleagues, who are accountable for the GRA Solution support function, about wider communication messages regarding solution support topics

  • Leadership of the Business Support User group. Ensure that the team is operating in a harmonized and efficient manner with respect to operations of the Business User support function.

  • Ensure accurate and timely support to user access requests for GRA systems managed by the Business User Support group . (eg, includes but not limited to publishing solutions, tools, document management systems, systems for the administration of user accounts and access management systems / processes).

  • Lead the group in support areas including user accounts, templates, user support. advanced system utilities. Independently perform advanced system administration activities to ensure optimum support to business needs.

  • Provide support for regulatory applications with the goal of preventing minimal solution downtime

  • Alert management of potential issues and project conflicts

  • Collaborate with appropriate stakeholders to identify and resolve issues to assure seamless integration of regulatory applications regarding administration, document development, publishing, submission, and archive activities.

  • Coordinate with ITS colleagues to implement and support new technologies.

  • Coordinate solution outage with appropriate user communities

  • Perform periodic review of user accounts as per compliance schedule established for GRA solutions

  • Leverage knowledge to help the UAT Lead and group to design, and write User acceptance scripts

Knowledge, Skills & Competencies / Language

  • This position requires a high degree of technical and Regulatory domain knowledge, customer service with multiple interfaces with partners and customers within and outside of Sanofi (this includes all R&D, Affiliates, GPE, Industrial Affairs and Commercial. The position requires experience in managing complex issues in a global environment

  • Customer service training and background with technical aptitude, skills and knowledge with the ability to support and lead resolutions around data dictionaries, document and dossier creation / storage, retrieval of documents, and software life-cycle management in respective GRA applications

  • Understanding of submission document types

  • Must be proficient using Document Management and similar technical tools

  • Strong knowledge of data, document, and dossier management processes and technologies

  • Solid expertise and effective use of data analysis tools and collect, summaries and present information

  • Strong knowledge of the drug development process and of the major submission documents for the CA, EU, JP, US, and International regions within GRA.

  • Keen verbal and written communication skills. Demonstrated ability to multi-task and to work in a global team environment, customer focused and action oriented.

  • Experience in management of global teams

  • Customer focus and action oriented

  • Ability to work with shifting priorities to meet project requirements

  • Self motivated

  • Ability to effectively lead and/or participate on teams

  • Perform duties with integrity and trust; composure, and perspective

  • Strong organizational and communication skills

  • Problem-solving skills and the ability to construct investigations to collect data aimed to support a pre-determined hypothesis

  • Recognize when sufficient data has been collected to solve a problem

  • Solid expertise and effective use of data analysis tools to collect, summarize and present information.

  • Excellent attention to detail

  • Strong interpersonal and collaboration skills

  • Process oriented with knowledge in Operational excellence

  • Strong organizational, and communication skills

  • Ability to work under pressure to meet short deadlines

  • The ability to understand the great importance of database accuracy

  • Experience in problem-solving techniques

  • Ability to lead multi-disciplinary teams and interface with upper level management of support and client organizations

Qualifications

  • Bachelor's degree in science, library or information management or equivalent experience. Minimum six years experience in the pharmaceutical industry with a minimum of four years in regulatory affairs and three years in the Registration Data domain

  • Strong knowledge of Regulatory Affairs/Operations domain and regulatory requirements

  • Strong Veeva VAULT RIM and Business Objects Universe design, creation, testing and technical skills are desired

  • Strong understanding of the different domains within Regulatory Affairs including Dossier Creation and Submission Management, Labeling, Document Management and reporting needs.

  • Working knowledge of regulatory requirements in multiple jurisdictions

  • Ability to lead multi-disciplinary teams and interface with upper level management of support and client organizations

  • Strong interpersonal skills to be effective in the leadership of global teams

Challenges of the job

  • Understanding user requirements and applying current technology to business problems

  • Dealing with diverse client personalities and managing expectations about timelines.

  • Establishing working relationships with key global business clients. Issues resolved by working closely with client, keeping abreast of application changes and assessing their impact on the user community, understanding and keeping abreast of systems security matrix changes.

  • Cultivating business relationships with colleagues GPE, IA, GRA, regions, affiliate and ITS.

  • Anticipation of requirements that will arise during regulatory inspections and audits

  • Ensuring that roles and responsibilities are clearly defined among various stakeholders participating in the solution strategy, design and implementation

  • Ability to quickly analyze the impact of new system releases

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.

#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.

DirectEmployers