Medical Advisor

Job description

MEDICAL ADVISOR

About the Opportunity

This role is key for medical supervision and medical management of clinical trials in various countries, clusters and across the region. The Medical Advisor is the medical link between Medical Operations (and/or Units/Customers) and (potential) investigators or experts/KOL in countries.

He/she is the medical support for the studies conducted by the Clinical Studies Unit (CSU) in the territory he/she is allocated to (e.g. advise on patient eligibility for participation in clinical research trials, assess clinical cases of individual patients in clinical research trials reported in the clinical monitoring reports, provide medical information to Health Care Professionals, in clinical research trials (protocol, investigational product). He/she provides appropriate medical feed back to the central clinical trial team especially to the Clinical Study Director and Feasibility Manager.

He/she provides medical support (e.g.: monitor patient safety during the conduct of clinical research trials and conduct the appropriate follow up of adverse events, medical evaluation of PV cases which are reported during clinical trials, identification of safety signals, advise Health Care Professionals on reporting of (serious) adverse events during clinical research trials, verify translations of individual adverse event cases from local language to English) for the local PV unit upon request. He/she helps, when necessary with answering medical questions from Health Care Professionals concerning (investigational) products and advising on trial related medical problems (e.g. questions from medical information, the monitoring team, investigators, etc.).

The North Sea Cluster includes Germany with satellite countries Austria, Switzerland, Luxembourg and the Netherlands.

Key responsibilities

·  Conduct pre-assessment and/or assess the feasibility of international and local protocols in his /her country(ies) in liaison with the Clinical Project Leader (CPL) and study team by collecting information and documentation on the study to be performed and by conducting surveys with opinion leaders, experts or potential. investigators and Health Authorities according to Clinical Study Director (CSD) and Feasibility Manager (FM) (Medical Operations) requirements and timing.
·  Strong network with local potential investigators.
·  Provide expert scientific advice and leadership while managing a broad range of activities Page 2 of 4 JD CSU NL – Medical Advisor 01/12/2017 KEY RESULTS/ACCOUNTABILITIES associated with the assigned product(s) and therapeutic area(s).
·  Local scientific knowledge and lobbying allowing capture of country specific information on competitive intelligence and validation of global hypothesis from the Clinical Development Plan or assessment of Extended Synopsis (ES)/protocol contents.
·  Liaise with local Medical Affairs within Sanofi in his /her country(ies) to manage investigators and compounds.
·  First-line medical support to the CSU/Clusters team, e.g. lead the answering of medical questions from investigating sites, ethics committees, monitoring teams (MTs), study managers (should include also appropriate interaction with CSD and global team).
·  Ensure medical & scientific training to the monitoring team and others (including good understanding of material provided by the Global team (e.g.; Firecrest modules, …).
·  Participation to CSUs/Cluster management and orientation.
·  Conduct appropriate review of patients’ data (e.g. patients’ profiles, e-CRF data, …) especially for critical cases (outcome events, related SAEs, AEs with pre-specified monitoring, translations of AEs) in order to support MT and Cluster Clinical Safety Officer (CSO) and achieve data quality.
·  Ensure quality of local/regional Investigator Meetings regarding medical content, ethics and interaction with investigators.
·  CSU preferred point of contact for Medical Operations to review and to provide medical input on proposed ES, protocol and/or Clinical Development Plan and medical practices in countries, cluster or region.
·  Contribute to the exchange of relevant information between R&D and Medico- Marketing department regarding clinical activity of the CSU/Cluster and support the handover of R&D products to marketed compounds.
·  Promote participation of the country, cluster or region for any clinical study and maintain and expand the investigator network in his/her country.
·  Support the affiliate’s network of KOL and experts when selecting National Coordinators or members of Study Committees.

About you

To excel in this role you will need to have:

·  Medical Degree with local medical board certification (i.e. a licence to practice medicine).
·  Minimum of 2 years post-qualification clinical experience (medical specialties or General Practice preferred).
·  Medical leader with clear and effective communication, Interest and ability to teach, Customer (CSD, FM, investigators, MT, …) & quality focused.
·  Basic I.T. skills in, e.g. Word, Excel, PowerPoint, E-mail, are essential. Further training in Page 4 of 4 JD CSU NL – Medical Advisor 01/12/2017.
·  Demonstrated ability to evolve in a complex environment.
·  Negotiation skills.
·  Effective management skills.
·  Management of communication and information.
·  Team-working Knowledge and Skills Knowledge of the principles of clinical trial design, management, analysis and reporting, including legal requirements, Good Clinical Practice (GCP) guidelines, scientific principles and ethical guidelines.
·  In addition to English and mother tongue, ability to speak other languages used in the countries of the cluster (or even the Region) would be an advantage.
·  Qualification in a medical specialisation highly desirable.

What Sanofi can offer you

·  A generous package including flexible benefits.
·  A healthy work-life balance throughout your career with us.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences.  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 employees, patients and customers.

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 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.