Regulatory Data and Content Professional (Senior Medical Writer)

TL;DR

Regulatory Data and Content Professional (Senior Medical Writer): Lead the development and execution of regulatory content strategies for global submissions, driving high-quality regulatory documentation across the product lifecycle with an accent on clinical dossiers, safety documentation, and compliance. Focus on reviewing and integrating complex scientific content for global health authority submissions, ensuring inspection and audit readiness, and coordinating cross-functional delivery.

Company

hirify.global is an independent technology consulting firm providing guidance and solutions to businesses.

What you will do

• Develop and execute regulatory content strategies for submissions to global regulatory authorities.
• Manage preparation of clinical dossiers and safety documentation for pharmaceutical products and/or medical devices.
• Create content plans and timelines aligned with overall project schedules.
• Review regulatory documents for scientific accuracy, clarity, consistency, organization, and regulatory compliance.
• Drive key messaging and content integration across submission documents and resolve content-related issues with cross-functional stakeholders.
• Maintain inspection and audit readiness; stay current with evolving regulatory guidelines and scientific/therapeutic area developments.

Requirements

• Bachelor’s degree or higher in Life Sciences or a related scientific discipline.
• Minimum 5 years of experience in pharmaceutical/biotechnology regulatory writing, medical writing, or regulatory content management.
• Strong knowledge of global drug and/or medical device development processes and regulations, including ICH, GCP, GxP, ISO, and MDR/IVDR guidelines.
• Expertise in clinical and/or safety regulatory documentation across the product lifecycle, from early development through post-marketing.
• Proven ability to analyze and synthesize complex non-clinical and clinical data from multiple disciplines.
• Fluent English (written and spoken).

Culture & Benefits

• Hybrid work mode based in Mississauga, Ontario, Canada.
• International environment with 110+ nationalities.
• Training system with an internal Academy and 250+ modules.
• Trust-focused culture and frequent internal events (afterworks, team buildings, etc.).