Senior Regulatory Medical Writer

We're Hiring: Senior Regulatory Medical Writer

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Experience Level: Senior

Work Arrangement: Fully Remote

About Us

We are a globally focused organization committed to supporting pharmaceutical, biotechnology, healthcare, and life-science development through high-quality scientific, medical, and regulatory documentation. Our multidisciplinary teams combine medical writing, clinical research, regulatory affairs, pharmacovigilance, statistics, clinical operations, quality, and scientific expertise.

Our teams collaborate across the product lifecycle to transform complex clinical and scientific data into accurate, consistent, evidence-based documents that support regulatory submissions, health-authority interactions, product approvals, and ongoing lifecycle management.

The Role

We are seeking an experienced Senior Regulatory Medical Writer to lead the preparation, development, review, and coordination of regulatory and clinical documents supporting pharmaceutical and biotechnology programs.

The ideal candidate will combine strong medical-writing expertise with an understanding of clinical research, regulatory requirements, scientific data interpretation, and submission standards. The role will work closely with Clinical, Biostatistics, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Quality, and subject-matter experts to deliver accurate, submission-ready documentation within demanding timelines.

Key Responsibilities

• Lead the preparation of high-quality regulatory and clinical documents throughout the product development lifecycle.
• Develop, write, and coordinate regulatory documents in accordance with applicable regulatory requirements and submission standards.
• Prepare clinical study reports, clinical summaries, clinical overviews, briefing documents, regulatory responses, and other submission materials.
• Draft and coordinate Common Technical Document sections and related regulatory documentation where applicable.
• Prepare clinical documentation for initial marketing applications, supplemental applications, variations, and lifecycle submissions.
• Develop submission-ready documents based on clinical, statistical, pharmacovigilance, and nonclinical source data.
• Review source documents and identify relevant clinical and scientific information for inclusion in regulatory documents.
• Interpret complex clinical and statistical data and present findings accurately and objectively.
• Translate technical and statistical information into clear, concise, scientifically appropriate regulatory language.
• Ensure regulatory documents accurately reflect source data and approved study plans.
• Develop clinical study reports in accordance with applicable regulatory guidance and organizational standards.
• Prepare study design, methodology, patient disposition, efficacy, safety, and conclusion sections for clinical documents.
• Integrate tables, listings, figures, statistical outputs, and other clinical data into regulatory documents.
• Review statistical outputs and confirm consistency between narrative text, tables, figures, listings, and underlying datasets.
• Work with Biostatistics and Data Management teams to resolve data discrepancies and interpretation questions.
• Coordinate document development with Clinical Operations, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and other stakeholders.
• Lead document planning meetings, authoring kickoffs, review meetings, and resolution discussions.
• Develop document outlines, writing plans, timelines, review schedules, and submission milestones.
• Establish clear responsibilities and deliverables for authors, reviewers, contributors, and subject-matter experts.
• Manage multiple regulatory-writing projects across different products, indications, studies, and development phases.
• Track document progress, review cycles, comments, approvals, and submission deadlines.
• Coordinate internal and external review cycles and ensure comments are appropriately resolved.
• Consolidate reviewer comments and facilitate resolution of substantive scientific, medical, statistical, and regulatory issues.
• Ensure final documents are internally consistent, logically structured, scientifically accurate, and submission-ready.
• Apply applicable regulatory guidance, international standards, company procedures, and document templates.
• Maintain consistency with relevant ICH guidelines and applicable regional regulatory expectations.
• Support preparation of regulatory briefing packages and meeting materials for health authorities.
• Prepare written responses to regulatory authority questions and information requests.
• Support preparation of responses to deficiency letters, review comments, clarification requests, and other regulatory correspondence.
• Ensure regulatory responses are scientifically supported, accurate, concise, and aligned with approved product information.
• Support preparation and maintenance of product labeling documents where applicable.
• Draft or support clinical sections of prescribing information, summaries of product characteristics, package inserts, and related documents.
• Coordinate cross-functional review of labeling and ensure consistency with clinical and safety evidence.
• Support development of risk-management documentation and other post-approval regulatory materials where applicable.
• Prepare or support periodic clinical and safety-related regulatory documents.
• Work with Pharmacovigilance teams on safety narratives, aggregate safety information, and regulatory safety documentation.
• Ensure consistency between clinical documentation and pharmacovigilance outputs.
• Review clinical documents for appropriate presentation of adverse events, serious adverse events, deaths, discontinuations, and other safety findings.
• Support preparation of integrated summaries of safety and efficacy where applicable.
• Ensure documents accurately describe study populations, treatment exposure, efficacy outcomes, safety findings, and benefit-risk considerations.
• Conduct comprehensive document reviews for scientific accuracy, consistency, readability, grammar, terminology, and regulatory compliance.
• Perform quality-control checks against source data, protocols, statistical analysis plans, tables, figures, and approved reference materials.
• Identify inconsistencies, missing information, unsupported statements, and discrepancies between documents.
• Maintain traceability between source data and regulatory narratives.
• Apply appropriate medical and scientific terminology consistently across documents.

Key Performance Indicators

• Regulatory document delivery rate
• On-time document completion
• Regulatory submission milestone adherence
• Clinical study report completion
• Regulatory document quality
• First-pass review acceptance
• Document review-cycle efficiency
• Number of major review comments
• Comment-resolution turnaround time
• Source-data accuracy
• Data-to-text consistency
• Table, listing, and figure consistency
• Regulatory compliance rate
• Document quality-control pass rate
• Medical terminology consistency
• Reference accuracy
• Document version-control accuracy
• Submission-readiness rate
• Regulatory query response timeliness
• Regulatory response quality
• Health-authority request turnaround time
• Cross-functional review completion
• Reviewer comment closure
• Document rework rate
• Writing-cycle time
• Regulatory submission support effectiveness
• Clinical data interpretation accuracy
• Safety-data presentation accuracy
• Efficacy-data presentation accuracy
• Integrated summary quality
• Labeling consistency
• Regulatory document traceability
• Electronic submission compliance
• Publishing issue rate
• Audit and inspection readiness
• SOP compliance
• Training completion
• Junior writer competency development
• Medical-writing process improvement
• Template and content-reuse adoption
• External writer performance
• Stakeholder satisfaction
• Regulatory milestone success
• Submission-quality performance

Ideal Candidate

The successful candidate should have strong experience in regulatory medical writing, clinical medical writing, pharmaceutical development, regulatory submissions, clinical research, or a closely related field, preferably within pharmaceutical, biotechnology, clinical research, or other regulated life-science environments.

The candidate should demonstrate:

• Proven experience preparing regulatory and clinical documents for pharmaceutical or biotechnology programs.
• Strong knowledge of regulatory medical-writing principles and clinical-development processes.
• Experience writing and coordinating clinical study reports.
• Experience preparing regulatory submission documents and Common Technical Document sections.
• Strong understanding of clinical trial design, conduct, analysis, and reporting.
• Ability to interpret clinical and statistical data accurately.
• Strong understanding of efficacy and safety data presentation.
• Experience integrating tables, listings, figures, and statistical outputs into regulatory documents.