Senior/Principal Medical Writer

Accountabilities
Lead the preparation of complex clinical and regulatory documents, including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications. Collaborate with clinical development teams, subject matter experts, and stakeholders to produce accurate, compliant, and scientifically robust documentation. Provide document-specific guidance and strategic writing support to clients and project teams. Manage document timelines, review cycles, and project deliverables while ensuring quality standards and regulatory requirements are met. Coordinate and oversee contributions from other medical writers, quality control specialists, and supporting team members. Monitor project budgets, follow internal procedures, and ensure successful delivery within agreed timelines. Work effectively within client regulatory document management systems and maintain high standards of documentation practices. Act as a trusted partner throughout the clinical development process by providing expertise beyond technical writing. Requirements Several years of professional experience writing clinical regulatory documents within the pharmaceutical, biotechnology, or healthcare industry. Proven experience as a lead writer for multiple regulatory document types, including at least three of the following: Clinical Study Protocols, Clinical Study Reports, CTD Clinical Summaries, Investigator Brochures, IMPDs/INDs, or scientific publications. Senior-level candidates should have experience leading more than three regulatory writing projects, while Principal-level candidates should have experience leading more than five projects. Principal-level experience with multiple CTD dossier types, such as new chemical entity applications, variations, generic dossiers, orphan drug dossiers, or literature-based submissions, is highly desirable. Experience working directly with clients, authors, and cross-functional teams while managing review processes, meetings, and project timelines. Strong understanding of regulatory documentation standards and experience using document management and review tools. Bachelor’s, Master’s, or equivalent degree in a scientific or pharmacy-related discipline; a Ph.D. is not required. Excellent written and spoken English skills with strong attention to detail and commitment to producing high-quality scientific content. Strong interpersonal and communication skills, with the ability to collaborate effectively with diverse teams. Ability to manage multiple priorities, remain focused under tight deadlines, and work independently in a remote environment. Benefits Fully remote work environment with flexibility within Europe. Opportunity to contribute to meaningful clinical development programs in the pharmaceutical industry. Competitive compensation package aligned with experience level. Standard benefits package and professional development opportunities. Opportunity to work with experienced medical writing professionals and international teams. High level of ownership and responsibility across impactful regulatory projects. Supportive environment focused on collaboration, quality, and continuous growth.

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