Manager Medical Writing

The Lotus Group LLC; Princeton (NJ); Hybrid; USD 150,000 - 170,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Medical writing experience

Regulatory submissions

Oncology experience

Writing and editing skills

Organizational skills

Education

Advanced degree (PhD, PharmD, MD or equivalent)

Job description

Manager, Medical Writing

We are seeking a Manager, Medical Writing to play a hands‑on role in the development of regulatory and clinical documentation for an oncology‑focused pipeline. This position will have significant responsibility for regulatory submissions, including Module 2 summaries, and will partner closely with Regulatory Affairs, Clinical Development, and Biometrics.

Base pay range

$150,000.00/yr – $170,000.00/yr

Key Responsibilities

• Author, review, and coordinate regulatory and clinical documents with a strong emphasis on submission content
• Lead development of Module 2 documents, including clinical summaries and overviews, in collaboration with Regulatory Affairs and Clinical Development
• Contribute to and support the preparation of IND, NDA, and BLA submissions
• Author and review clinical study protocols, clinical study reports, investigator brochures, and related documents
• Manage document planning, timelines, and review cycles across multiple programs or studies
• Ensure content is scientifically accurate, consistent, and aligned with regulatory expectations and company standards
• Partner cross-functionally with clinical, biometrics, pharmacovigilance, and regulatory teams to align on data interpretation and messaging
• Support continuous improvement of templates, writing processes, and documentation standards

Qualifications

• 4+ years of medical writing experience in industry, a CRO, academia, or a combination
• Demonstrated experience supporting regulatory submissions, including Module 2 content
• Oncology experience strongly preferred
• Advanced degree preferred (PhD, PharmD, MD, or equivalent), but not required
• Solid understanding of ICH guidelines and global regulatory documentation standards
• Strong writing, editing, and organizational skills, with the ability to manage multiple deliverables concurrently

Location (hybrid on‑site model)

• Bay Area, CA or Princeton, NJ