Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
Senior Medical Advisor
Job ref.: R2515595
Job Grade: L2:2
Department: Medical Affairs
Direct Managers Title: China & EM Medical Head & Country Medical Chair [NGGH & SSA]
- Responsible for developing and delivering medical affairs plan of defined therapy area(s) for Nigeria & Ghana in collaboration with GBU Medical Franchise lead, in line with both the global strategy and the specifics for the country (standards of care, market access constraints, population specifics. Etc)
Job Purpose and Key Responsibilities
NGGH Medical Affairs:
- Development of Medical Affairs Plan for the NGGH affiliate.
- Ensuring expertise in the field of medical affairs, medical excellence and medical operations.
- Planning and implementation of local Medical Affairs activities within the agreed timelines and budgets applying the knowledge of Sanofi and competitor products and therapeutic options and understanding the disease environment.
- Prioritization and definition of activities/ development areas to meet all scientific and medical needs as well as clinical care gaps
- Identification and engagement of Key Scientific External Experts [SEE] to gather insights and topics for discussion needed to inform medical strategy and implement initiatives defined in Medical Affairs Plan
- Incorporates risk management (assessment, minimization and mitigation) into all project plans.
- 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.
- Provides input to business colleagues in the development of the promotional materials, and reviews it ensuring all regulatory and compliance requirement to be met
- Plans and executes national and regional Advisory boards/Expert Input Forums, contributes to Sanofi sponsored meetings / CME events including the engagement of SEEs, development of supporting material (slide kits, digital materials etc.) and giving own lecture as relevant active participant in symposia and congresses.
- Provides medical and scientific training to internal customers and ensures tailored responses to customer’s requests for Medical Information.
- Closely collaborates with Market Access for access plans and programs and provides support when it comes to market access dossier preparation.
- Shares important and relevant information with the team / appropriate stakeholders
- Knows and understands Sanofi policies/procedures as well as industry regulations and standards and can apply them in the daily business understanding the value of quality and compliance and the implications and risks of non-compliance.
- Collaborate cross-functionally with other departments within the organization to ensure successful and ethical launch and commercialization of all products throughout their life cycle for optimal patient benefit.
- Provide medical support for the regulatory department, and acts as compliance monitor for trials, ensuring compliance with global and local SOPs and ICH GCP guidelines
- Manage Medical Affairs managed access programs for Sanofi NGGH unregistered medicines
NGGH Medical Operations:
- Secure the implementation of RMMs in line with company commitments and polices.
- Ensure development & updating local medical and regulatory affairs SOPs
- Manage the medical quality function through auditing various medical activities to ensure the implementation of SOPs in collaboration with NGGH & SSA Medical Operations Lead
- In collaboration with Medical Operations leads, perform ad hoc audits when needed.
- Follow up on the corrective action plan for the recommendation of audits.
- 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
- Planning, initiation and implementation of Local Clinical Evaluation, Patient assistance Support programs [in collaboration with Business Operation Support], including the production of a clinical study report and publications when applicable
- Develop and manage corporate and local medical affairs data generation programs.
- Secures clinical research and development by ongoing interaction with clinical study unit, key external experts and investigators to ensure continued involvement in international multi-centre clinical trials.
- Responsible for scientific communication of local post marketing trial results, including presentations of study results at local and international congresses.
- Support in application and management of IIS proposals received
- Build study protocols and validate the synopsis for all types of local data generation projects (RWE, RCT, Epidemiology registries etc.).
- Follow-up the clinical studies and fill Matrix and ClubNet data base accordingly.
- Ensure timely publication of all company sponsored studies (CSS)as well as resulting scientific communicating materials.
Job-Holder Entry Requirements
- Must have medical degree [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
- 3 or more years’ experience in medical affairs or clinical research function in pharmaceutical industry is desirable
The following skills are essential:
- Understanding of health systems and medical landscape and understands the need to shape the medical landscape.
- Engagement in continuous learning within a therapy area, whilst acting as the definitive repository of clinical/scientific knowledge for the internal commercial organization and becoming a trusted expert amongst external partners and opinion leaders.
- Ability to generate and utilize business insights to guide business strategy development and lay the foundation of an impactful medical plan.
- Lead the development and implementation of the scientific exchange activities for and proactively manage knowledge and information about a brand in line with business strategy through traditional and emergent communication channels in a compliant way to ensure that the value proposition of the company’s products is fully understood.
- Ability to implement trustworthy, non-promotional services to fulfil corporate obligations whilst providing customer interactions which enhance the reputation of the company.
- Leads the acquisition, generation, and interpretation of structured and unstructured clinical and scientific data to support the company’s medical and business objectives and obligations.
- Ability to leverage stakeholders’ insights together with expert scientific/medical knowledge for medical value proposition design and delivery to impact stakeholder behaviour.
- Ability to successfully initiate, plan, execute, monitor, and close assigned operational activities in a logical sequence, and within given constraints and resources to achieve goals. Successfully incorporates risk mitigation strategies, quality assurance measures, and routinely measures and reports progress versus plan to key stakeholders.
- Knowledge of relevant Regulations, Guidelines, Good Practices, both national, regional and international applicable to affiliate operations
- Strong presentation and communication skills.
- Objective driven and detailed Oriented
- Computer knowledge.
- Medical and scientific knowledge
- Methodology of clinical research, good clinical practice
- Influencing, communication
- Planning and Organising
- Fluent English speaking and writing
- Business Acumen
- Internal: Marketing, Medical & regulatory, other relevant departments.
- External: Medical practitioners, Pharmacists, Pharmaceutical and regulatory bodies
Method of Application
Interested and qualified? Go to Sanofi career website on sanofi.wd3.myworkdayjobs.com to apply