Department : Sanofi Genzyme Rare Disease Medical Japan
Job Title : Medical Manager Rare Disease
Job Scope :
The purpose of the Medical Manager Rare Disease position is to support the Rare Disease Medical Head to establish, implement, and execute on strategic objectives, operational and project budget planning and reviews, as well as coordination and project management of transversal projects, whether franchise / product-team specific or across teams.
Within the Franchise assignment, specific responsibilities include, but are not limited to :
Lead and monitor the execution of the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables.
Communicate the details and progress of the Medical Plan to local Medical Team, the JPAC / Global Medical and all parties responsible for execution.
Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of a particular brand(s) / projects.
Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development.
Provide medical review or support to the medical designee for scientific review and approval of promotional material and medical materials in compliance with corporate standards and government / industry regulations.
Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to local health authority).
Review, approve and supervise all aspects of clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines and the accurate and timely reporting of study data.
Oversee conduct of all clinical studies in adherence to both Company standards, and government / industry regulations (GCP / ICH).
Lead the review and approval of the concepts / protocols of Post-Authorization Safety / Effectiveness Studies (PASS / PAES), Investigator Sponsored Study (ISS) and Diagnostic Testing Programs, according to applicable SOP(s).
Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within pertinent medical community.
Fosters the establishment and maintenance of external scientific advisory boards and assists in advocacy development (in conjunction with JPAC Medical).
Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc.
Key accountabilities :
Office-based Medical accountabilities
Demonstrates understanding of health systems and medical landscape and integrates this knowledge in the design and delivery of the medical strategy.
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.
Generates and utilizes business insights to guide business strategy development and lay the foundation of an impactful medical plan.
Leads 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.
Implements 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.
Leverages stakeholders’ insights together with expert scientific / medical knowledge for medical value proposition design and delivery to impact stakeholder behavior.
Has organizational awareness of cross functional interdependencies, articulates and creates buy-in for vision, goals, strategy.
Accountable for business results. Plans, organizes and executes.
Understands business model, growth and profitability drivers. Demonstrates critical, risk-benefit thinking in the context of incomplete and ambiguous information.
Decisive and understands the impact (short- and long-term tradeoffs) on the company’s business. Assumes accountability and is customer centric and market orientated.
Analytical rigor in decision- making (considering alternatives and consequences.) Identifies opportunities and threats in a timely manner.
Gives direction, gains commitment. Develops empowers others and manages conflict well.
Manages change. Expresses self clearly. Listens, seeks to understand. Keeps people informed, up-to-date, drives innovation and business improvement, and challenges the status quo.
Be impactful. Influences people and processes, demonstrates courtesy, sensitivity, and respect, builds relationships, networks, partnerships and trust.
Demonstrating integrity, credibility, accountability, decisiveness, exercising judgement, problem-solving, emotional self-awareness, ability to self-motivate (set personal goals and measure success).
Pro-active, takes initiative, demonstrates ambition, commitment, perseverance, results focus and mental agility
Deals with first-time situation effectively. Self-development, self-awareness, maintaining self-control and focus, Demonstrating adaptability, flexibility, resilience, stress tolerance
8-10 years. Relevant experience in Medical Affairs. MD / DO preferred. Doctorate (PhD, PharmD or advanced degree) with relevant experience.
Excellent communication and presentation skills with the ability to present scientific data in a credible manner.
Able to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific / medical arena.
Strong understanding of the pharmaceutical / biotech drug development and commercialization process.
Leadership skills; personal style that includes a sense of urgency, as well as flexibility and ability to respond to rapidly changing environments and circumstances.
Collaborative and proactive, with a hands-on, roll-up-the sleeves style and attitude.
Highest integrity; committed to ethics and scientific standards.Working knowledge of English as a second language
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.