Senior Specialist Medical Services

Job Description

The Senior Specialist Medical Services is a role within the Europe, Middle East Africa, and Canada (EMEAC) Global Medical and Value Capabilities (GMVC) Hub in Global Medical and Scientific Affairs (GMSA).
The role is responsible for the core function of medical/scientific review of promotional and scientific materials for designated country/countries and above market level review as required.

Responsibilities:

Medical/Scientific Review:

• Conducts independent medical/scientific review of content/materials created by Country/Cluster or Region Human Health (HH, which is comprised of our Company’s commercial and marketing organizations responsible for our HH prescription medicines and vaccines), or GMSA, that describes product, disease, or both and is intended to be:

  • Presented or distributed to external customers, or

  • Used for training field-based employees, including field Medical Staff and field-based HH personnel
     

• Ensures all:

  • Content is medically/scientifically accurate, truthful, clear, relevant, complete, scientifically balanced, non-misleading and is accompanied by appropriate context

  • Medical and scientific statements within content/materials are supported by reliable and appropriate scientific evidence by evaluating supporting references and aligning with the Company’s Reference Standards

  • Communications are appropriate for the intended audience

  • Content adheres to applicable country laws and regulations, industry guidelines, Our Company’s Values and Standards, Policies, and Standard Operating Procedures (SOPs), and is respectful in terms of taste and tone

  • Review decisions are recorded in the appropriate System of Record by content type, and

    • Ensures all promotional materials align to the appropriate Product Circular (an additional responsibility for reviewers of HH promotional content)

    • Serves as a member of the Promotional Review Team (PRT)
       

• Provides expert clinical guidance and advice based on scientific evidence and clinical context to relevant stakeholders in the development of in-scope medical and scientific content

• Supports Country Medical Director/s for designated country/countries as local point of contact and subject matter expert (SME) for medical review

• Serves as product SME during GMSA global assurance process for country assessment and country audits and inspection, for designated country/countries

• Participates in Regional/Sub-Regional/Cluster/Cross-market/Country Agile Digital Engagement Teams for agile content collaboration on digital promotional materials

• Participates in the collaborative effort in responding to complaints from competitors and/or National Regulatory authorities and similar

• Stays abreast of internal and external changes to the environment affecting medical review and promotional activities, ensuring these changes are addressed in a timely and appropriate manner

Cross-Functional Collaboration

• Participates in departmental initiatives within Centralized Medical Services team that impact process improvements and fosters innovation and cross-functional collaborations.

• Partners with Regional MI Lead, Regional Medical Review Lead, and other key stakeholders (e.g., other reviewers of Promotional Materials, Medical Directors, Medical Advisors, Compliance) to ensure assets are available with the appropriate content to meet the needs of external customers and internal stakeholders.

• The Medical Services Specialist serves as a strategic partner and liaison between countries within a centralized team and among local or regional functional stakeholders as required (e.g., Commercial, Legal, Compliance, Medical Affairs, Digital, Public Affairs, Regulatory, and advertising agencies) to facilitate the Company’s promotional material review process efficiently and effectively.

• Partners with Country/Cluster/Region HH colleagues on promotional material related initiatives and on implementation of innovative solutions.
   

General

• Completes all required company training to ensure compliance with company policies and standards

• Ensures awareness of and compliance with Company policies, procedures, guidelines, and ethical standards, as well as all applicable local (for country/countries of responsibility) and regional regulations as applicable.

Required Qualifications, Skills, & Experience:

• Advanced degree (Medical Degree/Pharmacist Degree/equivalent [MS/ PhD, PharmD in life sciences])

• Knowledge of the Europe