Overview

Global Head of Medical Writing - AI

Reports to SVP, Global Head of Clinical Sciences and Operations

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 be the primary champion for modernizing our medical writing capabilities. You will bring experience or capability to integrate Artificial Intelligence (AI) and Generative AI (GenAI) to identify opportunities, drive digital transformation, and deliver next-generation writing solutions that reduce cycle times, enhance quality, and streamline global regulatory submissions.

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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. This involves leveraging artificial intelligence to drive workflow efficiencies, optimize time management, and increase agility. Additionally, the role will utilize AI-driven data mining to expand information reach, ensuring the creation of robust, highly 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 medical writer) signs off on automated sentences to prevent AI "hallucinations", particularly in relation to 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: Ensuring that 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): Responsible for generating patient-centric, layperson summaries of clinical trial results, which are legally mandated in many regions (like the EU CTR).

• Trial Registries: Management of 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 are leveraging the same technological advantages.

Qualifications

Education:

• Advanced degree in a life science discipline (Ph.D., PharmD, or Master’s degree) is highly preferred. Bachelors degree is required

Required Experience:

• Industry Experience: Minimum of 10–12+ years of experience in regulatory/medical writing within the pharmaceutical, biotech, or CRO industry and 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.

Please note: This position is classified as a corporate office position. In accordance with the New York state employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Base Salary Range of $278000-$301,000

Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

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The Company

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.

Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.

Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF).

Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.

Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.

It is an exciting time in the company’s development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline’s Oncology business.