Principal 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.