Remote Associate Director, Medical Writing (Oncology)

Meet Life Sciences Ltd.; EUA; Teletrabalho; USD 140 000 - 190 000; Tempo integral

Resumo da oferta

Meet Life Sciences Ltd. seeks an Associate Director of Medical Writing to provide strategic leadership across clinical development programs, with a focus on regulatory writing for oncology and neurology.

You will develop high-quality documents and partner with cross-functional teams to ensure scientific, quality, and regulatory standards. The role includes overseeing external vendors, authoring and editing protocols, CSRs, and Investigator’s Brochures, and supporting INDs and NDAs.

Qualificações

• 8+ years of medical writing experience in biotech, pharma, or life sciences.
• Bachelor's degree required; advanced degree preferred.
• Experience with protocols, CSRs, Investigator’s Brochures, and regulatory submissions.
• Experience supporting INDs and NDAs, especially oncology regulatory writing.

Responsabilidades

• Provide medical writing leadership across clinical development with focus on oncology and neurology.
• Oversee external vendors and contractors to ensure timely, high-quality deliverables.
• Author, review, and edit clinical and regulatory documents (protocols, CSRs, IIBs, regulatory submissions).
• Collaborate with clinical, regulatory, statistics, and pharmacovigilance teams to coordinate documents.
• Establish and improve medical writing processes, templates, quality standards, and review practices.
• Support regulatory submission planning and execution (INDs, NDAs, key clinical summary documents).

Conhecimentos

Scientific writing

Regulatory knowledge

Project leadership

Cross-functional collaboration

Attention to detail

Formação académica

Bachelor's degree in a scientific field

Advanced degree preferred

Descrição da oferta de emprego

Meet Life Sciences Ltd. seeks an Associate Director of Medical Writing to provide strategic leadership across clinical development programs, with a focus on regulatory writing for oncology and neurology.

You will develop high-quality documents and partner with cross-functional teams to ensure scientific, quality, and regulatory standards. The role includes overseeing external vendors, authoring and editing protocols, CSRs, and Investigator’s Brochures, and supporting INDs and NDAs.