Global Medical Affairs Publications Lead

ShionogiFlorham Park, NJ
3dOnsite

About The Position

The Global Medical Affairs Publication Lead holds overarching responsibility for the coordination, strategic oversight, and delivery of publication activities within the approved Global Publication Plan. The Publication Lead works in close collaboration with the Global Scientific Lead, who develops and owns the Global Publication Plan, while the Publication Lead coordinates and manages the execution of the plan in partnership with regional publication managers. This includes leading and managing publications for multiple assets across different therapeutic areas, ensuring scientific consistency, strategic alignment, and high-quality outputs across the portfolio. The role ensures full integration of global and regional needs and provides leadership across cross-functional and cross-regional partners to drive timely, compliant scientific publications. Beyond operational delivery, this position leads global coordination, ensuring alignment with regional publication managers, consistency in scientific messaging across markets as defined by the approved Global Publication Plan, and effective implementation of the global strategy. The role supports strategic planning, facilitates global communication, and ensures all publication activities adhere to Shionogi SOPs, GPP, ICMJE, and industry best practice. This role does not independently determine scientific strategy, data interpretation, or scientific conclusions, but ensures that publication execution aligns with the approved Global Publication Plan and established scientific governance.

Requirements

  • Bachelor’s degree in life sciences or related field; advanced degree (MS, PhD, PharmD) preferred.
  • Minimum of 12 years of experience in medical/scientific publications within pharma, biotech, or medical communications.
  • Expertise in Good Publication Practice (GPP), ICMJE authorship criteria, and industry-standard publication practices
  • Direct experience engaging with authors, external experts, medical writers, and cross-functional stakeholders
  • Expertise leading global or multi-regional publication programs in a matrixed environment
  • Proven ability to manage multi-asset and multi-therapy publication portfolios with competing priorities
  • Successful at partnering with regional publication managers and coordinating cross-regional execution
  • Experience managing publication vendors, including performance monitoring and quality assessment
  • Proficiency with managing and owning publication budgets
  • Demonstrates deep expertise in publication standards and governance frameworks, ensuring all activities comply with internal SOPs and external requirements (GPP, ICMJE, journal standards).
  • Leads complex, multi-asset publication execution with precision, discipline, and accountability to timelines and quality standards.
  • Effectively coordinates publication activities across regions to ensure consistent execution and alignment with global strategy.
  • Builds trust and drives outcomes through influence rather than formal authority across scientific, medical, and regional stakeholders.
  • Ability and willingness to travel approximately 20% of the year both domestically and internationally
  • Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.
  • Office presence required at least 50% of the time per month

Nice To Haves

  • advanced degree (MS, PhD, PharmD) preferred.

Responsibilities

  • Global Publication Planning & Coordination Work in close collaboration with the Global Scientific Lead, who develops and owns the Global Publication Plan, to ensure alignment and consistent global execution.
  • Provide oversight of the approved Global Publication Plan, ensuring timely and compliant delivery.
  • Work alongside regional publication managers to ensure publications are delivered in line with timelines and key scientific messages for a consistent execution globally.
  • Lead global publication planning meetings and cross-regional alignment discussions, ensuring consistent communication of the scientific narrative.
  • Ensure global plan updates are communicated effectively across all involved regions and functions.
  • Strategic Project Leadership Lead, coordinate, and manage activities related to the delivery of manuscripts, abstracts, and posters at a global level.
  • Oversee timelines, deliverables, and resources, anticipating issues and proactively addressing risks.
  • Drive high-level collaboration and facilitate decision-making with external experts, cross-functional teams, and publication vendors in accordance with the approved Global Publication Plan.
  • Governance, Compliance & Quality Oversight Ensure all publications comply with GPP, ICMJE, and internal SOPs/Work Instructions/Work Guidance.
  • Oversee quality control of publication materials and documentation to maintain audit readiness.
  • Ensure global consistency in authorship identification and adherence to authorship criteria.
  • Guide regional partners on global standards for publication processes, governance, and compliance requirements.
  • Execution and Budget Management Provide oversight of global publication budgets and ensure cost-effective allocation of resources within approved financial and governance standards.
  • Tracks spend and escalate potential variances from the approved budget.
  • Support global vendor management, including performance monitoring and quality assessment.
  • Stakeholder & Cross-Regional Leadership Act as the central point of contact for global publication activities, facilitating communication across regions.
  • Lead global publication team meetings and ensure transparent, consistent communication of project status.
  • Partner closely with regional publication managers, scientific leads, medical writers, and publications managers to synchronize efforts and ensure timely global delivery.
  • Cultivate strong relationships with internal and external stakeholders to support efficient and compliant publication execution.
  • Other duties as assigned.
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