Overview As Principal Medical Writer, you will lead the creation of high-quality clinical and regulatory documents to support global submissions. You will serve as the lead writer for key summaries and guide cross-functional teams to align messaging with program goals and regulatory expectations. You'll manage multiple complex projects, mentor writers, and drive process improvements to enhance quality and efficiency. This role places you at the heart of cross-functional collaboration to shape pivotal documents like IBs, CSRs, and regulatory submissions.
Responsibilities- Lead development of clinical and regulatory documents (e.g., IBs, CSRs, clinical summaries, regulatory submissions) in line with ICH, FDA, EMA and internal standards
- Serve as lead writer for key summary documents across multiple compounds/programs
- Provide strategic guidance on document content, messaging, and regulatory positioning to support program goals
- Manage medical writing projects including planning, timelines, and resource coordination to meet milestones
- Collaborate with Clinical, Regulatory Affairs, Biostatistics, Safety, and other teams to accurately present data
- Mentor and support other medical writers to ensure high-quality, consistent deliverables
- Review and edit documents for accuracy, clarity, consistency, and template/style compliance
- Participate in meetings to provide input on document development and process improvements
- Lead process improvement initiatives to enhance efficiency, quality, and consistency in document prep
- Develop, maintain, and refine SOPs, templates, and best practices for medical writing
- Stay current with global regulatory requirements and industry trends to ensure compliance and innovation
Key requirements- Bachelor's degree in a scientific, clinical, regulatory, or related field
- 7+ years of medical writing experience in biopharmaceutical, biotechnology, or CRO settings (or equivalent in clinical/preclinical development)
- Strong knowledge of global regulatory guidelines (ICH, FDA, EMA) across clinical development
- Broad understanding of clinical research processes, study design, data analysis, and regulatory submissions
- Proven ability to lead writing activities for complex documents and provide strategic input
- Excellent written and verbal communication skills for presenting complex information
- Strong organizational, time management, and project management abilities
- Ability to work collaboratively across functions while also operating independently
- High attention to detail, commitment to quality, and scientific accuracy
- Proficiency in Microsoft Word and document formatting best practices
- cross-functional collaboration
- clear communication
- attention to detail
- Microsoft Word
- document formatting best practices
- regulatory writing standards
