Global Head of Medical Writing

Reports to SVP, Global Head of Clinical Sciences and Operations

About the role

We are seeking a visionary and strategic Global Head of Medical Writing to lead our worldwide medical writing organization. In this critical leadership role, you will oversee a globally distributed team of direct reports while strategically managing a Functional Service Provider (FSP) model to ensure the seamless delivery of high-quality clinical and regulatory documents. As a forward-thinking leader, you will champion the modernization of our medical writing capabilities, integrating Artificial Intelligence (AI) and Generative AI (GenAI) to drive digital transformation, reduce cycle times, enhance quality, and streamline global regulatory submissions.

Responsibilities

• Global Team Leadership & FSP Management
  • Direct Leadership: Lead, mentor, and develop a high-performing, globally distributed team of internal medical writers and managers. Cultivate a culture of scientific rigor, continuous learning, and innovation.
  • FSP Strategy & Oversight: Manage and optimize our global FSP partnership model. Ensure scalable resource allocation, monitor key performance indicators (KPIs), and maintain seamless integration between internal teams and FSP resources.
  • Resource Allocation: Dynamically forecast and balance workloads across internal staff and FSP partners to meet dynamic pipeline demands efficiently.
  • Role Evolution: Lead the transition from a traditional medical writing model to an "AI-augmented editor" framework, leveraging AI to drive workflow efficiencies, optimize time management, and increase agility. Utilize AI-driven data mining to expand information reach, ensuring robust, accurate, and comprehensive medical documents.
• AI Strategy, Opportunities, & Innovation
  • AI Vision & Roadmap: Define and execute a multi-year strategy for integrating AI and automation into the medical writing lifecycle.
  • Process Transformation (Opportunities): Identify high-value opportunities to leverage AI for data-to-text automation (e.g., automated patient narratives, CSR generation, and protocol drafting) while maintaining strict regulatory compliance and data privacy.
  • Change Management: Act as the strategic ambassador for AI adoption, guiding the global team and FSP partners through the cultural and technical shifts required to embrace AI-assisted workflows.
  • The "Human-in-the-Loop" Mandate: Establish protocols ensuring that an experienced human interface (such as a medical writer) signs off on automated sentences to prevent AI "hallucinations," particularly in regulatory documents.
• Medical Writing Deliverables & Compliance
  • Portfolio Oversight: Ensure the timely, accurate, and compliant delivery of all clinical and regulatory documents, including Investigator’s Brochures (IBs), Clinical Study Protocols, Clinical Study Reports (CSRs), and CTD modules for NDA/MAA submissions.
  • Quality & Standards: Establish and enforce global medical writing standards, SOPs, and templates, ensuring alignment with ICH, GCP, and other global regulatory guidelines.
  • Audit Trail Compliance: Ensure the validation process for any AI-assisted document is fully documented and "inspection-ready" for regulatory audits (FDA/EMA).
  • Cross-Functional Collaboration: Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, and Clinical Development to align on study and submission timelines.
  • Plain Language Summaries (PLS): Generate patient-centric, layperson summaries of clinical trial results, which are legally mandated in many regions (e.g., EU CTR).
  • Trial Registries: Manage disclosures on sites like ClinicalTrials.gov and EudraCT.
• Key AI Deliverables Expected in Year One
  • AI Readiness Assessment: Deliver a comprehensive audit of current writing workflows to identify immediate bottlenecks suitable for AI intervention.
  • Pilot Implementation: Successfully produce documents utilizing an AI-assisted drafting tool for a standard regulatory document (e.g., CSRs or patient narratives) with measurable ROI.
  • Vendor AI Alignment: Establish updated SLAs and operating procedures with our FSP partners that incorporate AI utilization, ensuring both internal and external teams leverage the same technological advantages.

Requirements

• Education: Advanced degree in a life science discipline (Ph.D., PharmD, or Master’s degree) is highly preferred. Bachelor’s degree is required.
• Industry Experience: Minimum of 10–12+ years of experience in regulatory/medical writing within the pharmaceutical, biotech, or CRO industry, with oncology work experience.
• People Leadership: Minimum of 5+ years of experience directly managing and developing a global team of medical writers.
• FSP/Vendor Management: Proven track record of implementing, managing, and optimizing an FSP model to scale writing resources globally.
• AI & Technology Acumen: Demonstrated experience evaluating, piloting, or implementing AI/GenAI solutions within clinical or regulatory workflows, including experience with Structured Document Components or Validated AI Systems in a GxP environment. Deep understanding of the opportunities and limitations of incorporating AI solutions in a highly regulated pharmaceutical environment.
• Expert-level knowledge of ICH guidelines, global regulatory requirements (FDA, EMA, PMDA), and eCTD document structuring.
• Exceptional written and verbal communication, cross-functional stakeholder management, and a high degree of comfort navigating ambiguity to drive technological change.

Pay

Base Salary Range of $278,000–$301,000

About the Company

Founded in 1886 in Naples as Farmacia Internazionale, Menarini moved to Florence in 1915, where the Group’s headquarters remain today. The Menarini Group is an Italian pharmaceutical company with nearly 135 years of history, present in 70 countries with products sold in 140 locations worldwide. Its companies span Europe, Asia, Africa, the Middle East, Central America, and the United States, where the acquisition of Stemline Therapeutics marked its entry into the US oncology market.

With around 18,000 employees, Menarini produces over 500 million packs of drugs annually across 18 manufacturing sites, including a biotech plant for monoclonal antibodies. The company has a strong commitment to oncology, investing in a pipeline of five investigational compounds for hematological and solid tumors. The acquisition of Stemline Therapeutics in 2020 further strengthened its oncology portfolio, adding commercial and clinical-stage assets.

Key oncology products include Tagraxofusp, a first-in-class targeted therapy for blastic plasmacytoid dendritic cell neoplasm (BPDCN) and the only approved treatment for BPDCN in the U.S. and EU. Tagraxofusp is also being evaluated for other CD123+ indications. Menarini also holds exclusive rights to commercialize Selinexor, a first-in-class oral Selective Inhibitor of Nuclear Export for hematologic cancers and solid tumors, in Europe, Latin America, and other regions. Additionally, Menarini is developing Elacestrant, an oral SERD for hormone receptor-positive advanced breast cancer, which received FDA approval in January 2023.