Senior Medical Writer - Oncology & Regulatory

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Hybrid; EUR 73,000 - 115,000; Full time

Benefits offered by this job

Hybrid work model

Remote work options (case-by-case)

Job summary

Johnson & Johnson is seeking a Medical Writer III, Regulatory Medical Writing to support Oncology within the Integrated Data Analytics & Reporting (IDAR) organization. The role may be located Beerse, Belgium; Leiden, Netherlands; High Wycombe/Maidenhead, UK; Toronto, Canada or Spring House / Titusville, United States.

It is Hybrid (3 days onsite weekly) with remote work options considered case-by-case. You will lead document planning, coordinate cross-functional reviews, and mentor junior

Qualifications

• University/college degree in a scientific discipline required.
• Advanced degree (Masters/PhD/MD) preferred.
• 6+ years in pharmaceutical/scientific industry with 4+ years regulatory medical writing.
• English writing and speaking essential; ability to collaborate across time zones.

Responsibilities

• Write or coordinate regulatory documents (CSRs, IBs, protocols, RMPs, regulatory responses).
• Lead cross-functional document planning and review meetings.
• Interact with cross-functional colleagues on document content and processes.
• Establish document timelines and strategies with supervision.
• Lead writer for most compounds or submissions under supervision.
• Mentor junior staff and provide peer reviews.

Skills

Business Writing

Clinical Research and Regulations

Clinical Trials Operations

Coaching

Collaboration

Communication

Copy Editing

Data Synthesis

Industry Analysis

Medical Affairs

Medical Communications

Problem Solving

Process Oriented

Proofreading

Quality Standards

Research Ethics

Standard Operating Procedure (SOP)

Education

Bachelor's degree in a scientific discipline

Advanced degree (Masters/PhD/MD)

Job description

Johnson & Johnson is seeking a Medical Writer III, Regulatory Medical Writing to support Oncology within the Integrated Data Analytics & Reporting (IDAR) organization. The role may be located Beerse, Belgium; Leiden, Netherlands; High Wycombe/Maidenhead, UK; Toronto, Canada or Spring House / Titusville, United States.

It is Hybrid (3 days onsite weekly) with remote work options considered case-by-case. You will lead document planning, coordinate cross-functional reviews, and mentor junior