Medical Writer

Role purpose: To develop, coordinate, and deliver high-quality scientific publications and publication-related documents that accurately communicate clinical, regulatory, and scientific evidence, while enabling effective publication planning, vendor oversight, and cross-functional execution across the Clinical, Regulatory, R&D, and Medical Affairs functions.

Key responsibilities

Scientific publication writing and content development

• Write, edit, review, format, and finalize scientific publication deliverables, including manuscripts, abstracts, posters, congress materials, publication-enhancement documents, and other publication-related scientific outputs.
• Interpret, represent, and summarize clinical and scientific data accurately, clearly, and in a manner suitable for peer-reviewed journals, congresses, and external scientific audiences.
• Ensure publication content is scientifically balanced, non-promotional, evidence-based, and aligned with applicable journal/congress instructions, publication ethics principles, internal SOPs, and relevant guidance such as ICMJE and GPP.

Publication planning and prioritization

• Participate in annual and ongoing publication planning exercises, including identification, prioritization, and tracking of publication opportunities across products and therapy areas.
• Support development and maintenance of publication plans, publication trackers, milestone dashboards, and status updates to enable visibility on planned, ongoing, submitted, accepted, and published outputs.

Project management of outsourced publications

• Manage outsourced publication projects with external medical writing agencies/vendors, including scope alignment, briefing, kickoff, timeline planning, quality review, version control, stakeholder coordination, and delivery tracking.
• Coordinate vendor deliverables to ensure adherence to agreed timelines, scientific quality expectations, and internal review processes.
• Review vendor-developed drafts for scientific accuracy, clarity, completeness, consistency, formatting, journal/congress compliance, and alignment with internal publication objectives before stakeholder circulation.

Cross-functional collaboration and stakeholder management

• Collaborate closely with the Clinical, Regulatory, R&D, and Medical Affairs to fulfill publication requests and resolve scientific/content queries.
• Facilitate cross-functional author/reviewer inputs, consolidate comments, reconcile conflicting feedback, document decisions, and drive timely approvals across internal and external stakeholders.
• Engage with internal subject matter experts and external authors, where applicable, to support publication development while maintaining appropriate authorship, acknowledgment, and publication governance practices.

Compliance, documentation, and process excellence

• Ensure consistency with applicable internal SOPs, publication governance processes, and relevant legal, ethical, and compliance requirements.
• Maintain organized records of publication requests, drafts, reviews, author approvals, submission materials, correspondence, versions, and final outputs for audit-readiness and institutional knowledge management.
• Identify process gaps in publication development, vendor management, review workflows, archiving, and tracking; propose improvements and support implementation of publication process maps, templates, checklists, and metrics.

Capability building and mentoring

• Build and enhance competencies in publication writing, scientific communication, publication ethics, journal/congress requirements, and cross-functional project management.
• Train peers and cross-functional contributors on publication writing expectations, review discipline, reference/citation quality, version control, and adherence to publication timelines.
• Mentor and coach junior writers and support development of writing quality standards and best practices across the publication function.