Global Regulatory Writing & Consulting (GLOBAL)

• Responsible for the end-to-end planning, execution, and delivery of medical device regulatory writing projects across global regulatory frameworks. • Focus on EU MDR Clinical Evaluation (including CERs). • Support premarket regulatory submissions in either the United States (e.g., 510(k), De Novo, PMA) and/or EU MDR Technical Documentation. • Oversee complex documentation programs (e.g., CERs, PMCF, SSCPs, Technical Documentation, and premarket submission dossiers) and/or manage large client portfolios across multiple products and regulatory jurisdictions. • Provide leadership and operational oversight to a team of Medtech Medical Writers, ensuring high-quality, compliant, and timely deliverables. • Directing, delegating, and reviewing work; establishing clear project expectations; maintaining accountability for performance against timelines, budgets, and quality standards. • Interpret and operationalize regulatory requirements into executable project plans and writing strategies. • Drive continuous improvement of templates, processes, and workflows to enhance efficiency, scalability, and quality. • Contribute to business development activities, including marketing, proposal development, scoping, and client onboarding.

• Oversee and lead the development of high-quality scientific documents, including clinical study reports, regulatory submission documents, publications, and other medical communications • Collaborate with cross-functional teams, including clinical, regulatory, and medical affairs teams, to ensure the delivery of accurate, clear, and well-structured documents that meet industry standards and regulatory requirements • Develop and oversee the preparation of clinical study reports (CSRs), clinical study protocols, investigator brochures, regulatory submission documents (e.g., INDs, NDAs), and other scientific/medical documents • Ensure the accuracy, clarity, and compliance of all documents with internal guidelines, industry standards, and regulatory requirements • Review and edit documents for consistency, style, and adherence to medical writing best practices • Support the preparation of regulatory submission documents and assist in the response to regulatory agency inquiries • Contribute to the preparation of scientific publications, abstracts, posters, and presentations for medical meetings • Implement and maintain efficient medical writing processes and tools to improve the quality and efficiency of document preparation • Ensure that all writing adheres to current guidelines, including ICH E6, ICH E3, GxP, and other relevant regulatory requirements • Provide detailed reviews and edits for accuracy, scientific content, grammar, style, and formatting • Provide training and development opportunities for junior writers, improving their skills in clinical and regulatory writing.

• The Director of Medical Writing is a senior leadership role responsible for overseeing the strategic direction, management, and execution of medical writing activities across clinical, regulatory, and publication-related projects. • Collaborate with key stakeholders, and drive process improvements, all while contributing to the success of the company’s clinical and regulatory goals. • Oversee the preparation of all types of scientific and regulatory documents, including clinical study protocols, clinical study reports (CSRs), regulatory submissions (e.g., INDs, NDAs, BLAs), Investigator's Brochures, and other critical medical communications. • Ensure that documents are scientifically accurate, clear, and compliant with regulatory guidelines, corporate style, and industry standards (e.g., ICH, GxP). • Review and approve major documents to ensure alignment with overall scientific and regulatory strategy. • Collaborate with clinical development, regulatory affairs, biostatistics, pharmacovigilance, and other internal stakeholders to ensure seamless development and delivery of high-quality medical writing documents. • Ensure all medical writing deliverables comply with regulatory guidelines, ethical standards, and industry best practices. • Continuously assess and optimize the medical writing process to improve efficiency, reduce errors, and enhance document quality.