Senior Director, Medical Writing
hace 22 días
Cambridge
This is a newly created position and a foundational hire for Agomab's Medical Writing function. The Sr. Director, Medical Writing will serve as the anchor of our hybrid medical writing model — working embedded across all clinical programs, owning narrative strategy and document quality, managing CRO medical writing relationships, and building the institutional knowledge and processes that will scale with the pipeline into Phase 3. This role will also lead how AI-assisted tools are adopted and applied within the medical writing function, balancing efficiency gains with the accuracy, compliance, and audit-trail standards regulatory documents require. This is not a document production role. You will be expected to think and operate as a strategic partner with cross-functional stakeholders including Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, and Pharmacovigilance and other stakeholders, shape how documents tell the program development story, and establish the standards and tools that define how medical writing works at Agomab. • Author and lead the development of core regulatory and clinical documents across all programs, including clinical study protocols (Phase 1–3), clinical study reports (ICH E3), investigator's brochures, regulatory agency briefing documents (FDA Type C/D, EOP2, PreIND), scientific advice packages (e.g., MHRA, EMA), and pediatric plans (PIP/iPSP), • Own the narrative strategy for each document — not just execution — ensuring scientific accuracy, internal consistency, and alignment with the program's development strategy, • Author and edit IND/NDA/eCTD supporting documents including CTD Module 2/5 summaries, integrated summaries of safety and efficacy, and submission-ready clinical overviews as programs advance, • Establish and maintain documentation standards, templates, and best practices consistent with internal and external guidelines for regulatory documentation and submissions; drive innovative solutions to resolve issues, • Review regulatory, clinical, and safety documentation according to good documentation practices — evaluating organization, clarity, and scientific standards — to ensure consistency of content across the portfolio and compliance with worldwide regulatory requirements, • Support preparation of manuscripts and abstracts for peer-reviewed publications in collaboration with medical and clinical teams, • Build and maintain Agomab's medical writing template library, style guide, and standard operating procedures, ensuring documents are inspection-ready and submission-quality, • Serve as process owner and subject matter expert for regulatory documentation; lead the development of training and resources for writers and cross-functional partners regardless of reporting relationship, • Maintain current awareness of applicable regulatory guidelines (ICH E3, E6, E8, E9; FDA and EMA guidance; CTD/eCTD specifications; global disclosure requirements) and proactively apply updates to documentation standards, • Ensure consistent entry of data to support departmental metrics and analytics; define and track KPIs to evaluate impact on cycle time, quality, and operational efficiency, • Interface across multiple functions to influence regulatory documentation processes, mediate conflict resolution, and champion a culture that promotes meaningful collaboration and superior document quality, • Serve as the internal anchor and quality steward for all CRO medical writing engagements — select, brief, oversee, and review work from external writers, • Assess resource requirements across all projects; assign resources according to R&D priorities; prepare criteria and strategies for selection and management of external documentation support, • Establish quality standards, style guides, and review processes that apply consistently across internal and CRO-authored documents, • Manage timelines and deliverables for CRO medical writing workstreams, ensuring integration with program milestones and regulatory submission schedules, • Lead identification and implementation of AI-enabled use cases within Agomab — including draft generation, summarization, review support, and document comparison — while maintaining quality and compliance standards, • Establish and maintain responsible AI oversight, including risk management, validation approaches, and alignment with regulatory expectations, • Drive development of prompt libraries, reusable workflows, and training approaches to enable adoption across the organization, • Work comfortably with collaborative review platforms; bring experience or a clear point of view on which tools best serve a lean biotech environment, • Collaborate closely with Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, and Pharmacovigilance and other stakeholders to gather inputs, coordinate review cycles, and drive documents to completion on time, • Participate in program team meetings; contribute to regulatory strategy discussions by providing a medical writing perspective on document feasibility and timeline planning, • Work with Project Management to establish and maintain document planning triggers, lead times, and milestone-based scheduling for all clinical documents across the portfolio, • Develop and maintain document storyboards, writing kick-off guides, and integrated planning tools that support cross-functional alignment before drafting begins, • Contribute to the development of the Medical Writing function — including resourcing models, capacity planning, and the transition toward a dedicated internal function supporting multiple programs Qualifications • Bachelor's degree (BS) required; advanced degree (MS, PharmD, or PhD) preferred, in a life science, medical, or related discipline (e.g., life sciences, pharmacy, medicine, public health), • Minimum 15 years of regulatory medical writing experience in the pharmaceutical or biopharmaceutical industry, with demonstrated independent authorship of Phase 1–3 clinical documents, • Expertise and thorough knowledge of regulatory requirements and technical specifications for the assembly, structure, content, formatting, quality control, and submission of all document types within the CTD process, including management of associated health authority requests, • Strong, direct experience authoring protocols, clinical study reports (ICH E3), investigator's brochures, and regulatory agency briefing documents, • Extensive experience authoring and overseeing high-quality IND/NDA/eCTD supporting documents including CTD Module 2/5 summaries and integrated summaries of safety and efficacy, • Expertise and understanding of global and local disclosure laws, end-to-end drug development, and clinical trial processes, • Experience authoring pediatric development plans (PIP and/or iPSP), • Experience planning and leading strategic initiatives within a medical writing function, • Demonstrated AI proficiency, with experience supporting or contributing to AI strategy and tool adoption within a medical writing or regulatory function, • Demonstrated ability to manage multiple documents and programs simultaneously under competing deadlines, • Proven ability to operate independently with minimal oversight in a lean, fast-moving organization, • Strong cross-functional collaboration and communication skills — experience working directly with Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, and Pharmacovigilance and other stakeholders Preferred • Experience in GI and/or respiratory TAs, inflammatory disease, fibrosis, • Experience managing or overseeing CRO medical writing partnerships, • Hands-on experience with AI-assisted drafting tools and document automation workflows, • Familiarity with collaborative review platforms (Veeva Vault, Please Review, or equivalent), • Publications experience: manuscripts, abstracts, or conference presentations for peer-reviewed journals, • Experience in a small or early-stage biotech environment where the medical writing function was nascent or being established, • The opportunity to develop pioneering science in a young biotech company, • Challenging and innovative work environment as part of a driven team, • Flexibility and responsibility US-based (preferably East Coast); remote with periodic travel to Agomab's headquarters (Belgium) and US office (Boston) and key program meetings, • Competitive salary and benefits, • An agile and fast paced environment #J-18808-Ljbffr
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