Regulatory Business Operations Manager
Cambridge, MA;Bridgewater, NJ
Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.
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HEALTH AND WELLNESS PROGRAMS
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Employer matching because Sanofi invests in their employees!
Sanofi is eager to further your development and expertise in an ever challenging environment.
Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.
PAID TIME OFF
Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!
Importance of life outside of the office is valued at Sanofi.
The Regulatory Business Operations Manager requires a leader that has the ability to combine GRO operations understanding with quality, performance management, and vendor management. This individual would be responsible for developing and reporting GRO performance measures and aligning vendor performance monitoring to support. In addition, this individual will utilize strong quality and continuous improvement knowledge and skills to drive GRO quality and productivity.
He/She will support delivery of strategic project business cases as well as support development of new business cases for GRO including delivery of the monitoring mechanisms for performance and productivity for GRO.
This role will provide the reporting and oversight to support assurance that maximum benefit is achieved.
Duties & Responsibilities:
Performance Management / Vendor Management
- Generate Global Regulatory Operations (GRO) performance measures including performance measurement and productivity.
- Support delivery of business cases via contribution to RFP development and reporting on performance to achieve ROI.
- Drive vendor management strategy working in conjunction with the Business operations team.
- Generate Vendor performance measures including SLA monitoring, performance measurement and continuous improvement. Provide Vendor performance reporting.
- Define and track vendor KPIs to support Service Level as agreed with vendors.
- Contribute to RFP development, especially content related to performance and SLAs.
Quality / Continuous Improvement / Audit & Inspection
- Liaise with GRA Quality as related to GRO Quality management. This includes managing vendor quality to ensure Sanofi requirements are satisfied.
- Lead Vendor continuous improvement initiatives as required to support business case ROI delivery
- Manage GRO Audit and Inspection readiness. Lead the preparation of GRO for Audits and Inspections as required. Lead GRO Audit / Inspection execution as required.
- Manage and provide Quality documentation for Vendor qualifications for compliance
- Lead / participate in strategic projects for GRO as required.
- Manage project/initiative as directed, while setting and continually managing expectations with project leaders, vendors involved in the program and other stakeholders.
- Manage the timelines and ensure goal are accomplished per agreed charter and meet the required quality standards. Liaise with stakeholders on an ongoing basis an didentify possible interactions with other projects/operations.
- Key participant to develop and manage GRO M&A playbook including: resource/cost algorithms, standard plans, processes, tools sets, etc.
Knowledge, Skills & Competencies / Language
- Working knowledge of current (pref. Cloud-based) data visualization tools (QlikSense, Spotfire, SAP, Tableau, etc.) preferred
- Experience in contract services, tools, processes and techniques
- Experience working with or in functions that interface with Regulatory
- Experience in vendor contract management, performance monitoring and continuous improvement.
- Experience defining and leading continuous improvement projects
- Experience leading in a matrixed reporting structure
- Pharmaceutical or related industry experience required.
- Expert oral/written communication skills and presentation skills are also required.
- Demonstrated and Recognized capacity to multi-task and maintain attention to detail
- Ability to adapt to changing business priorities
- Strong organizational and excellent communication skills; proven ability to work in a matrix organization; established managerial, teamwork and project leadership skills, including problem solving and conflict management
- Ability to enable decision making and assess situations in order to minimize risk, yet make timely, wise, and pragmatic decisions
- Demonstrated values, behaviors, and working style needed to embrace change, drive to results, and cooperate transversally, including composure in high stress, tight deadline situations, diplomacy, tact, integrity and trust
- Confirmed ability to establish effective working relationships across different functions and cultures
- Position requires strong business acumen and proactive problem-solving skills.
- Position requires strong interpersonal/soft skills to influence others outside of the department or organization with whom Business Operations is dependent to achieve objectives
- Position requires the appropriate recognition and handling of confidential and sensitive information
- Incumbent may need to be available outside of regular business hours during high volume activity, such as contractor rollover, annual and periodic fiscal budget setting / reconciliation
- BA/MBA required for this position
- Minimum of 5 years of relevant experience in similar position
- Minimum of 5-10 years of Pharmaceutical R&D industry experience
- Continuous Improvement Certification (e.g. LSS Green Belt / Black Belt) preferred
Requirements of the job
- This position requires domestic and international travel
- This position will suit an individual who is able to operate with discretion and confidentiality about sensitive data
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.
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.
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