Medical Advisor at Sanofi

Department: Medical
Direct Manager Title: GEM Medical Head & Country Medical Chair NGGH & SSA
  
Job Purpose

• Provide to the NGGH affiliate the expertise in the field of medical affairs, medical excellence and clinical operations.
• Ensure compliance with company corporate and affiliate polices as well as local regulatory and legal obligations regarding the appropriate use of Sanofi products under his/her responsibility.
• Partners the commercial organization through integrated medical and scientific support and provide the scientific competence needed to ensure that Sanofi products reach the appropriate patient population. .

Key Accountabilities
Affiliate Medical Affairs:

• Provide up to date disease and product knowledge to internal and external stakeholders for assigned product(s).
• Support the development and execution of medical plans to optimise product value.
• Actively participate in cross-functional collaboration – Pharmacovigilance, regulatory, marketing, sales and public affairs – to support integrated plans across these functions
• Provide scientific input to post-commercialization clinical data generation programs (Phase IV, registries, RWE, etc.) for assigned product(s).
• Ensure data are scientifically valid and support the strategies, and are communicated effectively to relevant customers (reports, publications, presentation to congresses, or company sponsored events).
• Provide scientific support to the management of investigator sponsored studies in strict adherence to the Group’s policies and guidelines.
• Provide scientific input to other key medical activities for the assigned product(s) or tasks, including medical information service, epidemiology/health economics/outcome research, medical education, medical publication, etc. to support optimal execution of the medical plan.
• Closely work with regulatory and R&D to provide scientific input on unmet medical need assessment and product value proposition to ensure an optimal local registration strategy for new product and/or new indication.
• Provide medical and scientific support to the Company’s marketing and sales activities, including input in marketing strategy from medical point of view, round tables, symposia and medical education activities, liaison with external experts, scientific communications, sales training, and medical input in promotional materials and validation of their scientific integrity and compliance to the Group’s procedures.

Affiliate Medical Excellence:

• Secure the implementation of RMMs in line with company commitments and polices.
• Ensure development & updating local medical and regulatory affairs SOPs
• Ensure that the Medical Staff are trained on the relevant SOPs.
• Training for the newly hired Medical staff on the relevant SOPs
• Ensure that Patient Support Programs (PSPs) are complying with SOPs and guidelines.
• Ensure appropriate scientific and medical compliance, governance and risk management within the framework of optimised patient centred risk/benefit in the responsible product(s) or tasks
• Ensure that all SOPs are implemented and GCPs are applied.
• The clinical studies and fill Clear and ClubNet data base accordingly.
• Ensure that Clinical Study Reports (CSRs) are done as well as resulting scientific communicating materials.

Working Relationships:

• Internal: Marketing, Medical & regulatory, other relevant departments.
• External: KOL, Medical practitioners, Pharmacists, Pharmaceutical and regulatory bodies

Job-Holder Entry Requirements
Education: 

• Must have medical degrees [MBBS OR MD] from a reputable University.
• Postgraduate will be an advantage, e.g. Master degree or above in clinical medicine

Experience & knowledge: 

• 3-5 year clinical practice
• Experience in medical affairs or clinical research function in pharmaceutical industry is desirable

Core competencies:
The following skills are essential:

• Knowledge of relevant Regulations, Guidelines, Good Practices, both national, regional and international applicable to affiliate operations
• Overview of pharmaceutical business in Africa and pharmaceutical market knowledge of local country/ies.
• Autonomy with confirmed sense of urgency, priorities & self-control, capacity for problem solving
• Ability to interact efficiently with Competent Authorities/ Inspectorates.
• Ability to work transversally in a matrix organization & to foster a process simplification approach while meeting compliance requirements
• Strong presentation and communication skills.
• Computer knowledge.
• Methodology of clinical research, good clinical practice
• Business Acumen