Principal Medical Writer 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:

• BA/BS in English or life science.
• Minimum 8 years of MW experience in pharma (small pharma/CRO preferred).
• Proven experience leading complex clinical regulatory writing projects, including marketing applications.
• Ability to manage competing priorities in high-pressure situations.
• Strong understanding of drug development process and health authority regulations.
• Ability to analyze and summarize complex scientific and clinical data.
• Proficient in leading without formal authority (influence, negotiation, resourcefulness).
• Expert in Microsoft Word, eCTD templates, and document management systems.
• Mastery of the English language (written and spoken).
• Excellent organization, time management, and attention to detail.

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.