MSD Medical Operations Specialist 

Vietnam, Saigon 

783321223

Job Description

• Ensuring Country Medical Operations support to further develop and maintain a highly functioning V & I organization
• Taking responsibility for designated V & I GMVC Country and/or SEA/TW Cluster Medical Operations Support, including Communications, Process & Systems, Quality & Standards, Innovation and Emerging Projects, Business Intelligence, Knowledge Management, Medical Event and DPOC
• Taking responsibility for medical review of promotional material in AP MR Hub
• Collaborating with the Global and Country Medical Operations teams, GMVC AP Hub Team, and cross-functional stakeholders supporting designated AP SEA/TW Cluster Medical Operations & AP MR Hub initiatives

• Understands the mission and vision of V & I as a science-driven and patient-committed organization
• Stays current with key initiatives across Asia Pacific Medical Operations & Medical Review Hub and supports GMVC AP Hub SEA/TW Med Ops Lead & MR Hub Lead and fellow SEA/TW Cluster Country Med Ops colleagues in achieving deliverables against organizational priorities
• Supports GMVC AP Hub SEA/TW Med Ops Lead & MR Hub Lead overseeing complex initiatives with regional scope and impact aligned with key GMVC Medical Operations & Medical Review priorities
• Supports GMVC AP Hub SEA/TW Med Ops Lead & MR Hub Lead in collaborating with GMVC Medical Operations, Global Medical Information, and other GMVC colleagues to ensure alignment across the broader organization
• Supports GMVC AP Hub SEA/TW Med Ops Lead & MR Hub Lead in partnering with Country leadership team members across Global Medical Science Affairs, Global Clinical Development, Regulatory Affairs, Pharmacovigilance, and other cross-functional stakeholders in Our Company to define operational efficiencies
• Supports GMVC AP Hub SEA/TW Med Ops Lead & MR Hub Lead in presenting ongoing strategic project updates at Country Medical Science Affairs meetings, local Medical Governance meetings, and other relevant meetings
• Exhibits responsible subject matter expertise and business acumen

1) Medical Review

• Completes all required Company training to ensure compliance with Company policies and standards
• Performing independent medical/scientific review of content/materials created by Human Health that describes product, disease, or both as per Performing Medical Review Policy and SOP as well as applicable country regulations/pharmaceutical guidance,
• Competent to review any therapeutic area being assigned based upon language capability
• Executes Hub review standards, scope, timeline and communicates with Medical Science Affairs Med review team/Commercial to align expectations and support Country when needed
• Assists the GMVC AP Hub SEA/TW Med Ops Lead & MR Hub Lead in executing the quality assurance process as and when required, to ensure alignment and standardization across Therapeutic Areas (TA) and countries for all Hub reviewers
• Assists the GMVC AP Hub SEA/TW Med Ops Lead & MR Hub Lead as local point of contact and subject matter expert (SME) for medical review to facilitate regular refresher session/training to ensure Hub and Country reviewers are qualified and aligned with relevant Medical Review Policy/Procedure and local regulation
• Assists the GMVC AP Hub SEA/TW Med Ops Lead & MR Hub Lead in driving operational excellence in medical review through the simplification of processes, introduction and utilization of digital tools, and fostering collaborative partnerships with cross-functional teams.
• Delivers pre-defined, biannual customer survey and direct/indirect to internal stakeholder feedback

2) Other Hub Activities

• As the Point of Contact (POC) for Medical Operations, facilitates communication between countries and regional Hub; solicits county needs, concern and feedback to the Hub
• Coordinates with country Medical Affairs team to implement and manage Regional/Global digital enablement project, process and systems, and other innovation and emerging projects for optimizing medical operations
• DPOC:
  • Owner of the local DPOC mailbox and local DPOC procedure document
  • Offers training and guidance to outsourced vendors in local information relevant to DPOC-local laws and regulations, culture, tone, manner and in-country DPOC related cross-functional coordination
  • Provides DPOC Quality check for responsible countries to ensure DPOC Agent comply with global SOP
• Provides immediate back-up for relevant Hub activities in case Business Continuity Plan needs to be implemented

Process & Systems, Quality & Standards for Medical Operations and Medical Review

• Acts as SOP point of contact (POC) overseeing and supporting activities pertaining to the rollout, creation, review, and approval of Global/Regional/Country SOPs/Execution Resources (ERs)/Job Aids (JAs), aligning with Quality by Design, and maintaining stewardship and training responsibility for Global Medical Science Affairs SOPs/ERs/JAs
• Coordinates designated Global Medical Science Affairs operational activities, which includes but are not limited to: BI Dashboard, promotional material review system of record (SOR) and medical event SOR.
• Oversees designated Global Medical Science Affairs Process & Systems and metrics to ensure standard alignment with Regional and Global process
• Is the country (medical) single point of contact (SPOC) for Veeva PromoMats new account set up

2) Knowledge Management

• Supports Global Medical Science Affairs line manager in onboarding newly hired Global Medical Science Affairs members by assigning AP Onboarding journey learning items and facilitating Global Medical Science Affairs Onboarding - Line Manager Training Deck update. Also responsible for updating the Global Medical Science Affairs - Onboarding - Med Ops Training Deck
• Acts as the Country Knowledge Management Steward, providing support for My-learning item assignment and report generation for Global Medical Science Affairs members in the country as needed. Ensures compliance with global-required training goals, ensuring there are no overdue trainings.

Medical Event

• Assists the GMVC AP Hub SEA/TW Med Ops Lead & MR Hub Lead in executing Regional/Global Medical Event relevant initiatives

4) Audit

• Supports Country Medical Lead and GMVC AP Hub SEA/TW Med Ops Lead & MR Hub Lead for country audit readiness activities, coordinates interactions with auditors, prepares corrective and preventative actions (CAPA) and necessary follow-up

Communication

• Ensures alignment and facilitates effective communication among Medical Operations, GMVC, and key stakeholders across functions, such as Human Health, Research Lab, Compliance, Legal, Finance, IT, Manufacturing division etc.

• BS/PharmD/MS/PhD plus 2+ year of relevant experience
• Fluency in English & local language (
  Vietnamese
  ) (written and verbal)
• IT literacy, particularly with Microsoft applications
• Strong personal integrity and high ethical standards
• Close attention to detail and high level of accuracy
• Experience in reading and interpreting clinical studies
• A thorough understanding of ethical guidelines relevant to the pharmaceutical industry to ensure compliance with external and internal guidelines and standard operating procedures
• Good interpersonal, negotiation, communication, and presentation skills
• Effective, versatile, and action-oriented approach
• Demonstrated experience in identifying process gaps and building new processes
• Demonstrated ability to effectively prioritize and manage multiple tasks simultaneously
• Demonstrated good decision-making skills and ability to weigh advantages, disadvantages, and business impact for rapid decisions
• Proactively contributes to a positive team attitude and a highly productive teamwork environment
• Good business and financial acumen and a customer focus
• Ability to respond to challenges actively and positively
• Awareness of digital innovation

• In-depth experience managing medical review
• In-depth experience managing medical operations, such as; process & systems, quality & standards, and knowledge management
• Experience and success in a teamwork-oriented, diverse, and inclusive environment

Current Contingent Workers apply

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

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.