Senior Medical Writer - FSP in Cambridge

We are seeking an experienced Senior Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that documents such as Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and marketing authorization applications (MAAs/NDAs/BLAs) are scientifically accurate, consistent, and aligned with program objectives and global regulatory requirements. The successful candidate will act as a lead writer for key summary documents, providing strategic guidance to cross-functional teams while overseeing medical writing activities across multiple compounds. This position reports to the Director of Medical Writing (or above).

Key Responsibilities

• Lead the development of high-quality clinical and regulatory documents (e.g., Investigator’s Brochures, Clinical Study Reports, clinical summaries, and marketing authorization submissions) in compliance with global regulatory guidelines (ICH, FDA, EMA) and internal standards.
• Serve as the lead writer for key summary documents, overseeing medical writing activities across multiple compounds or programs.
• Provide strategic guidance to cross-functional teams on document content, messaging, and regulatory positioning to ensure alignment with program goals.
• Manage medical writing projects, including planning, timelines, resource coordination, and delivery to ensure milestones and submission deadlines are met.
• Collaborate with cross-functional stakeholders (Clinical, Regulatory Affairs, Biostatistics, Safety, etc.) to gather, interpret, and accurately present clinical data.
• Mentor and support other medical writers, ensuring high-quality, scientifically sound, and consistent deliverables across projects.
• Review and edit project-related documents to ensure accuracy, clarity, consistency, and compliance with templates and style guides.
• Attend project and team meetings to provide expert input on document development, study data interpretation, and process improvements.
• Contribute to and lead process improvement initiatives to enhance efficiency, quality, and consistency in document preparation.
• Develop, maintain, and refine standard operating procedures (SOPs), templates, and best practices for medical writing.
• Stay current with evolving global regulatory requirements, industry trends, and therapeutic area knowledge to ensure compliance and innovation.

Qualifications

• Bachelor’s degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred.
• Minimum of 5+ years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered.
• Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development.
• Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements.
• Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams.
• Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information.
• Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines.
• Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed.
• High attention to detail with a commitment to quality, consistency, and scientific accuracy.
• Proficiency in Microsoft Word and document formatting best practices.
• Experience with electronic document management systems (eDMS) and familiarity with document templates, style guides, and structured authoring tools.