INTL - DDO Writing Consultant

Required Skills & Experience

-MSc or PhD in a relevant scientific discipline, or equivalent by experience. -Mid- to senior‑level experience in CMC regulatory dossier authoring for innovator products (non-generics). -Demonstrated strong understanding of Module 3 (and Module 2.3) content for global regulatory submissions. -Fluent written and spoken English. -7+ years of experience in CMC regulatory and/or technical writing within the pharmaceutical or biotechnology industry. -Strong scientific writing and document-management skills. -Ability to interpret complex technical information and effectively collaborate with scientific SMEs. -Ability to quickly learn and adapt to new digital tools, technologies, and evolving ways of working.

Nice to Have Skills & Experience

-Strong digital/technology aptitude with an interest in AI-enabled scientific or regulatory authoring. -Experience with GenAI, digital transformation, automation, structured content, or technology-enabled authoring tools.

Job Description

Our large pharmaceutical client is seeking DDO Writing Consultants to support the development and delivery of high-quality Chemistry, Manufacturing, and Controls (CMC) documentation for pharmaceutical development programs while contributing to a multi-year, enterprise-wide GenAI initiative focused on transforming regulatory authoring and dossier development.

Consultants will partner with CMC subject matter experts and cross-functional stakeholders to translate complex scientific and technical information into clear, accurate, submission-ready content while supporting the adoption of new digital and AI-enabled authoring capabilities.

Key Responsibilities:

-Act as project DDO Scientific Integrator on CMC teams, driving dossier strategy and execution with limited supervision. -Author, edit, and maintain CMC technical and regulatory documentation. -Synthesize complex CMC data and SME input into clear, consistent scientific narratives. -Support the transformation of regulatory authoring and dossier development through GenAI and digital capabilities. -Collaborate with CMC SMEs, regulatory stakeholders, and digital/technology teams to support evolving authoring workflows. -Coordinate content development, review cycles, and stakeholder feedback across CMC functions. -Ensure documentation is accurate, consistent, traceable, and aligned with established regulatory and quality expectations. -Support the evolution toward more automated, data-driven content creation and technical report generation.