Medical Governance Manager

Job description

About the Opportunity

As a Medical Governance Manager you will provide leadership across all staff to ensure that customer facing compliance (outside the scope of legal or financial compliance) can be effectively operationalized in the UK and Ireland. Specifically, they are accountable for:

·  Leading the operationalization of the defined customer facing compliance framework
·  Highlighting areas for improvement or potential risk for the organisation through evidence provided by audit and anomalies with proposed solutions

About Sanofi Business Unit

Reporting directly to the Head of Medical Governance, as a Medical Governance Manager for Sanofi UK and Ireland, you will play an integral role in ensuring a robust governance framework is in place which is understood and followed by all within the company. Helping drive a culture in which compliance with the regulations and codes of practice is everyone's responsibility you will be key to ensuring we continue to work in an ethical and transparent manner.

Key responsibilities

1) Lead governance, risk management and oversight of UK and Ireland ‘Code' and medical related activities as per the medical governance plan

·  Support the Head of Medical Governance in writing a strategic medical governance plan on an annual basis meeting the external and internal requirements
·  Manage the Medical and Code transversal company training requirements for all levels across the UK and Ireland as directed by the Head of Medical Governance
·  Provide strong leadership and consultancy to all personnel in the UK and Ireland to empower the implementation of the defined governance framework relating to medical and the relevant Code(s)
·  Build and manage the delivery of training appropriate to need and topic

2) Leadership in the designated medical governance process definition and improvement for ‘owned' processes including global alignment

3) Support audits in the Medical Governance arena as requested by the Head of Medical Governance, CCs, CMCs, GBU GMs or GBU Medical Heads in collaboration with the Audit and Monitoring Manager

·  Write the audit plan and methodology relevant to the question being reviewed
·  Implement or support others to implement the audit as requested
·  Recommend and implement CAPAs as appropriate to the findings
·  Lead in organisational CAPAs and change controls from external/internal changes or audit/monitoring results as requested by the Head of Medical Governance

4) Consult on process definition and improvement for other processes which incorporate Code elements within them. Provide relevant customer (internal and external) feedback into any medical governance related topics

5) Management of Resources

·  Updates systems in a timely way to reflect the current status of purchase orders and any deliveries of goods and services
·  Attends to invoice system requests and queries quickly and efficiently

About You

To excel in this role you will need to have:

Essential requirements:

·  Educated to at least degree level
·  Minimum 2 years' experience in compliance
·  Ability to identify opportunities and threats and plan responses accordingly
·  An understanding of the external environment: the NHS, Government policy, regulatory requirements and their application within the business context
·  Good understanding of the UK regulatory environment relating to promotion of pharmaceuticals, devices and OTC, self- care products including active signatory work
·  Experience in clinical trials, risk management and commercial pharmaceutical sector with active involvement in Code of Practice-related activities and GCP areas
·  Demonstrated leadership capability with proven track record of leading projects
·  Application of sound professional judgment to ethical issues
·  Experience in managing issues under pressure. Ability to make difficult decisions when required
·  Strong influencing and networking skills
·  Strong verbal and written communication skills required

It would be advantageous to have (not essential):

·  Medic or pharmacist trainings completed
·  Good understanding of the Irish regulatory environment

What Sanofi can offer you

·  A role where you are instrumental to creating best practice and as the organisation grows, you can too
·  We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us
·  The role is based in our office in Guildford. Moving to Reading in June 2019
·  This is a full time role and we support flexible working

About Sanofi

Empower Life Everyday

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we're not there to try to solve everybody's problems. We want to focus on those areas where we know we are making a difference.

The values we are live by are teamwork, courage, respect and integrity.

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.