MSD Senior Regional Medical Services Specialist 

Serbia, Central Serbia, Belgrade 

4028099

Job Description

• The Senior Specialist, Regional Medical Services (referred to as
  Regional Medical Services Specialist
  in the below description), is a regional based 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 functions of medical/scientific review of promotional and scientific materials for designated country/countries and regional level review; medical education and training of internal stakeholders; and where required, providing medical and scientific affairs services per designated country/countries, which may include the preparation of scientific documentation for internal and external customers.

• The Regional Medical Services Specialist has an advanced educational background (e.g., MD, PhD, PharmD, or equivalent MSc in Life Sciences) and reports into the Director, Medical Information EMEAC GMVC Hub.

Responsibilities and Primary Activities:

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

Medical Services Support:

• The Regional Medical Services Specialist assumes varying degrees of responsibility to support Medical Services activities as defined per designated country/countries.
• Where relevant or required for the role, Medical Services activities can include:
  • Vendor oversight activities at the level of designated country/countries as required (or back-up support, as required) for Designated Point of Contact (DPOC)/Medical Information (MI) activities handled by the vendor, which include DPOC/MI process assurance and quality checks
  • Support in the creation of local ad-hoc MI responses to MI requests (MIRs) from healthcare providers, for complex MIRs as escalated by DPOC/MI outsourced supplier
  • Scientific content ambassador for designated country/countries
  • Point of contact for DPOC/MI System of Record for designated country/countries
  • Partners with local and regional key stakeholders, including Pharmacovigilance and Manufacturing Division to ensure an effective and efficient end-to-end process for managing product safety and quality reports
  • Supports designated country/countries in responding and complying to any program investigations, audits, or assessments, working closely with EMEAC Regional Vendor Oversight and Quality Lead, local Pharmacovigilance and other stakeholders as required.

Medical Education and Training

• Collaborates with internal stakeholders to determine training materials and identifies training gaps. Contributes to the development/creation and delivery of scientific training materials to the Regional/Cluster/Country Medical Reviewers as relevant, and where required, DPOC/MI specialists.
• Provides training to business colleagues on topics related to promotional review standards, local code/s, and regulations for designated country/countries.

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. Over time, becomes a resource within the therapeutic area for the regional core functions of Medical Information (as applicable), Promotional Review, and Medical Education/Training
• The Regional 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, as well as Medical Review Certification training, before performing medical review
• 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 EFPIA and local Industry Code of Practice and experience of either creating or approving promotional materials within the pharmaceutical industry
• Excellent communication skills (internal and external), oral and in writing in local language and English
• Ability to understand customers, patients, as well as other external stakeholders’ views and needs
• High level of scientific and ethical integrity, always putting patient safety at the forefront
• Detail-oriented with ability to organize, prioritize, and work effectively in a constantly changing environment and effectively operate in a team-orientated structure as well as by oneself
• Excellent cross-functional collaboration skills
• Ability to work independently while escalating risks and issues as appropriate

Preferred

• >3 years Pharma industry experience in relevant Medical Affairs domain (e.g., medical/scientific review and/or, medical information)
• Strong collaboration skills and the ability to execute innovative ways of working within a complex matrix environment
• Excellent negotiation skills, able to diffuse tense situations comfortably, so that common ground is found
• Strong decision-making, problem-solving, and analytical skills, with ability to innovate with practical solutions for complex issues
• Experience as a member in cross-functional, global initiatives in a complex matrix
• Knowledge of diseases and drug therapies especially related to Our Company products is a merit

Languages

• Fluency in English
• Fluent in Serbian

Current Contingent Workers apply

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A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.