Manager, Medical Writing — Oncology Submissions Lead

The Lotus Group LLC; Princeton (NJ); Híbrido; USD 150.000 - 170.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking a Manager in Medical Writing to develop regulatory and clinical documentation for an oncology pipeline. The role includes authoring, reviewing, and coordinating regulatory documents and supporting regulatory submissions. Candidates should have at least 4 years of medical writing experience, preferably with a background in oncology and a solid understanding of ICH guidelines. This is a hybrid position based in Princeton, NJ.

Formación

• 4+ years of medical writing experience in industry, a CRO, academia, or a combination.
• Demonstrated experience supporting regulatory submissions, including Module 2 content.
• Solid understanding of ICH guidelines and global regulatory documentation standards.

Responsabilidades

• Author, review, and coordinate regulatory and clinical documents.
• Lead development of Module 2 documents in collaboration with Regulatory Affairs.
• Contribute to the preparation of IND, NDA, and BLA submissions.

Conocimientos

Medical writing experience

Regulatory submissions

Oncology experience

Writing and editing skills

Organizational skills

Educación

Advanced degree (PhD, PharmD, MD or equivalent)

Descripción del empleo

A leading company in the pharmaceutical sector is seeking a Manager in Medical Writing to develop regulatory and clinical documentation for an oncology pipeline. The role includes authoring, reviewing, and coordinating regulatory documents and supporting regulatory submissions. Candidates should have at least 4 years of medical writing experience, preferably with a background in oncology and a solid understanding of ICH guidelines. This is a hybrid position based in Princeton, NJ.