Principal Regulatory Medical Writer

Accountabilities:
The Principal Regulatory Medical Writer will be responsible for independently developing and managing complex clinical and regulatory documents while ensuring quality, compliance, and timely delivery. The role requires strong collaboration with internal teams, clients, and scientific stakeholders to support successful clinical development programs. Author, edit, and review high-quality clinical, safety, regulatory, device, diagnostics, and disclosure documents across different phases of research. Develop complex regulatory deliverables, including protocols, clinical study reports, investigator brochures, informed consent forms, patient narratives, submission-level documents, and other regulatory materials. Manage assigned medical writing projects, timelines, deliverables, and client expectations with minimal supervision. Coordinate cross-functional collaboration with clinical operations, regulatory affairs, biostatistics, data management, and other subject matter experts. Lead quality control activities, review documentation consistency, maintain audit trails, and support compliance with applicable standards. Ensure documents align with regulatory guidelines, including ICH standards, regional requirements, client procedures, and approved templates. Provide mentorship, training, and peer review support to less experienced medical writers. Participate in process improvement initiatives, knowledge-sharing activities, and departmental projects. Identify project risks, inefficiencies, and potential challenges while proposing solutions to improve quality and delivery. Maintain awareness of evolving industry practices, regulatory expectations, and medical writing standards. Requirements: The ideal candidate is an experienced regulatory medical writing professional with strong scientific knowledge, regulatory expertise, and excellent project management capabilities. This role requires attention to detail, independent ownership, and the ability to communicate effectively with diverse stakeholders. Bachelor’s degree or higher, preferably in a medical, scientific, healthcare, or related discipline. Minimum of 7 years of experience writing clinical and/or regulatory documents within a pharmaceutical, biotechnology, medical device, diagnostics, or contract research environment. Advanced knowledge of clinical research principles and the ability to interpret complex clinical data. Strong understanding of regulatory submission requirements, processes, and applicable global guidelines. Experience preparing documents for regulatory submissions such as IND, NDA, BLA, MAA, eCTD submissions, PBRER, and DSURs is preferred. Familiarity with standards such as ICH E3, ICH E6(R2), EU MDR/IVDR, and other regulatory frameworks. Excellent proficiency in Microsoft Word, including advanced formatting of tables, graphs, figures, and complex documents. Strong project management, organizational, and prioritization skills with the ability to manage multiple projects simultaneously. Exceptional written and verbal communication skills in English, with familiarity with AMA style guidelines. Strong stakeholder management skills and experience building strategic relationships with clients and internal teams. Ability to work independently, demonstrate initiative, and proactively address challenges. Experience mentoring or supporting the development of junior medical writers is a plus. Benefits: Opportunity to work on global healthcare and life sciences projects. Flexible work environment with remote work opportunities. Exposure to innovative clinical research programs and regulatory submissions. Professional development opportunities and continuous learning support. Collaborative environment with multidisciplinary scientific and healthcare experts. Career growth opportunities within a global organization. Inclusive workplace culture that values diversity, collaboration, and innovation.

How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
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