Develops and leads Medical Writing submission, authoring, editing, and document review strategies and standards across therapeutic areas and compounds, ensuring alignment with applicable regulatory guidance, industry standards, and internal quality expectations.
Leads the incorporation of technology into Medical Writing and Editing responsibilities, including authoring tools, editing platforms, automation, document management capabilities, and technology-enabled workflows that improve document quality, consistency, efficiency, compliance, and scalability.
Establishes, maintains, and continuously improves department guidelines, templates, standard timelines, quality standards, editing expectations, and SOPs to support consistent, compliant, and efficient document development and review.
Oversees Medical Writing and Editing activities supporting clinical regulatory documents, including planning, authoring, review coordination, quality control, editing, finalization, and delivery of submission-ready documents.
Develops and executes resourcing strategies, including internal staffing plans, editor and writer allocation, external consultant support, and outsourcing models for Medical Writing and Editing activities.
Tracks document development, editing workload, submission priorities, and long-term staffing needs, and allocates work appropriately among department members, external consultants, and vendors.
Provides leadership and guidance to Medical Writing and Editing staff, including oversight of document strategy, content development, editing standards, review processes, issue resolution, stakeholder communication, and delivery of high-quality clinical regulatory documents.
Manages and develops staff, including performance management, recruiting, coaching, training, annual performance reviews, succession planning, and professional development.
Represents Medical Writing at cross-company, compound, and therapeutic area meetings by driving discussion, presenting as a functional leader, articulating document strategy and timelines, identifying decision makers, and focusing teams on results and actions.
Leads and participates in technology adoption, process improvement efforts, standards development, and cross-functional working groups within Medical Writing and across Global Development.
Oversees external writers, editors, and writing projects to ensure deliverables meet internal process, quality, technology-use, and timeline expectations, including vendor selection, onboarding, collaboration management, and performance oversight.
Remains compliant with internal training requirements and ensures staff are appropriately trained on relevant Medical Writing, Editing, regulatory, process, and technology expectations.
Bachelor's degree (advanced degree preferred)
Minimum of 17years of industry experience to include a minimum of 10 years of Medical Writing experience
Minimum 7 years management experience
Expert knowledge of the clinical research process and regulations/guidelines
Expert clinical document reading, writing, and editing experience
Excellent organizational, interpersonal and communication skills
Excellent knowledge of MS Word, Adobe Acrobat, PowerPoint, electronic document management systems, authoring and editing platforms, document collaboration tools, automation-enabled workflows, and other technologies used to support clinical regulatory document development.
Demonstrated ability to evaluate, implement, and promote technology solutions that improve Medical Writing and Editing quality, consistency, efficiency, compliance, and scalability.
Ability to lead and manage multiple projects
Thorough understanding of ICH GCP guidelines
