Country Medical Affairs Manager - Roche

Objectives and Scope of Position:

• Launch and provide strategic direction a Medical Unit in Angola
• Contributes to the leadership and management of the Affiliate by providing strong functional expertise and ensuring it adheres to the highest scientific and ethical standards and fulfils all regulatory and compliance requirements
• Contributes to the collective Medical leadership of the Company and to the appropriate use of Roche products
• Represents Roche medical authority with key external stakeholders

The main responsibilities will be:

Management

• Manages the medical budget/resources and ensures prioritization of investments to meet the medical objectives (short and long-term)
• Builds strong relationships and ensures good collaboration and communication between Medical and other affiliate, regional and global functions

Medical strategy and tactics

• Provides strategic guidance and scientific leadership, defines and executes the affiliate long-term vision, including strategic partnerships
• Shapes development and delivery of affiliate medical plans, in alignment with Lifecycle plans. Aligns medical strategy development across functions, locally and globally. Collaborates with regions to evolve medical strategy
• Strategizes optimal mix of evidence generation investment and other medical activities
• Ensures strategic partnerships with TAEs, scientific institutions/societies, patient associations, cooperatives groups, health authorities and payers to support patient access and enable optimal use of Roche products

Evidence generation activities

• Is accountable for affiliate evidence generation portfolio management needed to enhance product knowledge and anticipate/support patient access according to the local needs and in line with global strategy
• If appropriate, oversees the development of medically sound, feasible affiliate studies which are approved and executed in compliance with all policies and regulations

Scientific communications (SC) and Medical Information

• Builds effective collaborations with external stakeholders and ensures integration of insights to support the medical strategy, including patient access
• Ensures medical and product information is provided in compliance with SOPs, local requirements and that all data used in the provision of Medical information are accurate and meet the needs of internal and external customers

Compliance and Training

• Is accountable to manage the local quality management system for the medical department.
• Ensures that all medical activities comply with Roche policies/SOPs and local regulations
• Evaluates and anticipates quality and compliance related risks. Provides clear guidance on appropriate actions
• Oversees medical review and approval of promotional materials. Ensures the accuracy of training material for scientific and product information

Drug Safety / Pharmacovigilance

• Ensures that processing and reporting of safety information is conducted in compliance with Roche SOPs and local regulatory requirements
• Ensures oversight of the safety of local clinical activities

Regulatory Affairs

• Establish effective relationships with Regulatory, Reimbursement and other health authorities to achieve registration of and access to products

Health Economics / Market Access

• Anticipates clinical/RWD data needed to accelerate patient access. Ensures clinical value evidence and medical contribution are provided to support HTA submissions

Who You Are

You are a dynamic person used and available to work in a fast changing market, with flexibility to adapt to the business circumstances and needs, to enable growth, sustainability and business compliance at the same time. You are a person engaged in providing African Patients the opportunity to be treated in their home countries like elsewhere.

For this position, you are required to bring the following:

Professional and Technical Requirements:

• Medical degree is preferred. Board certification in a medical specialty is appreciated
• Pharmaceutical medicine training is appreciated

Competencies:

• Ability to demonstrate Roche Values and Leadership Commitments
• High ethical standards
• Roche Core Competencies
• Highly organized, with ability to prioritize own tasks as well as those of others. Good planning skills
• Ability to provide clear strategic directions and to oversee the execution of medical activities
• High-level negotiation and influencing skills
• Strong interpersonal skills, with the ability to understand individual needs and motivation
• Excellent oral and written communication skills, including the ability to articulate clear messages from complex data/ information
• Ability to work across organization at all levels
• Business and financial acumen
• Fluency in the Portuguese and English language, oral and written

Experience, Skills, Knowledge:

• Substantial experience of practicing clinical medicine (if MD)
• Experience in the medical function of the biotechnology/pharmaceutical industry
  • Product development experience
  • Strong track record in strategic planning and implementation of key Medical affairs activities in data generation, scientific communications, medical education and external stakeholder management and cooperation
  • Clinical and post-marketing drug safety and risk management
  • External stakeholders engagement (incl. TAE, patient association, collaborative groups, Health authorities, payers)
  • Experience in product launches
• Leadership
  • Resources allocation and management
• Public speaking and presenting to large audiences
• In-depth understanding of medical and strategic aspects of all drug development stages
• In-depth understanding of medical strategies including integrated evidence generation (early phases to post marketing), knowledge sharing and scientific collaborations
• In depth understanding of the medical compliance framework (GCP/GVP), Health Care Compliance and Quality management
• Understanding of the local health care system, including regulatory and payer environment
• Understanding of the disease areas set as a priority for the Company

Other:

Decisions Making Authority

• Budget allocated to the Medical Department
• Medical Affairs Healthcare compliance. Final arbiter on promotional material and activities
• Medical Compliance: local decision maker on GCP/GVP/QMS topics including Regulatory compliance (even if DRA not reporting to cMD / where appropriate)

Context

This position is

• Member of the Unit Management reporting to the Business Development Lead for the PSC.
• Part of the PD Medical Affairs network

Accountable for

• Medical strategy for the PSC Markets
• Evidence generation activities
• Scientific collaborations and knowledge-sharing, incl. medical information, medical education and publications
• Strategic partnerships, incl. TAE collaboration, health authority interactions, Patient organizations,  Payers
• Pharmacovigilance
• Compliance to company guidelines and local regulations
• Media communication on medical issues
• Regulatory  Affairs**
• Health economics/market access**