What are the responsibilities and job description for the Principal Medical Writer position at Meet?
About :
Meet is partnered with a cutting-edge biopharmaceutical company, on their mission to treat cancer. They are a team of passionate individuals who are committed to making a meaningful impact on healthcare, and are seeking a Principal Medical Writer to join their growing team.
Responsibilities :
- Research, write, and edit complex clinical and cross-functional documents to meet regulatory requirements.
- Develop Phase 1-4 protocols and clinical study reports.
- Prepare investigator brochures, clinical IND modules, NDA modules, and responses for health authorities in eCTD format.
- Contribute to regulatory strategy and ensure documents align with key messages and labeling objectives.
- Ensure MW deliverables meet quality standards, templates, and regulatory / industry guidelines.
- Review draft eCRFs to ensure appropriate data capture.
- Review SAPs and mock tables / figures / listings for accurate reporting.
- Ensure compliance with ClinicalTrials.gov requirements (protocol registration, results reporting).
- Lead development and improvement of MW procedures, providing training for new procedures and technologies.
- Advise on MW best practices and technologies to improve regulatory document development.
- Mentor and manage less experienced personnel.
Qualifications :
Full job description and company details are available upon application. This position is being dealt with by Payton Baker at Meet, please email payton.baker@meetlifesciences.com if you would like to discuss more about this opportunity in confidence.
