Senior Regulatory Medical Writer - Hybrid & Lead Projects

Johnson & Johnson Co.; Leiden; Hybride; EUR 64 000 - 103 000; Plein temps

Résumé du poste

Johnson & Johnson in Leiden, Netherlands seeks a Medical Writer III, Regulatory Medical Writing, to support global regulatory documents across multiple therapeutic areas within IDAR. Hybrid model with potential multi-country postings; case-by-case remote options.

The role emphasizes leading document planning, mentorship, and cross-functional collaboration to ensure timely, compliant submissions. Requires 6+ years in pharma writing and strong English communication.

Qualifications

• A university/college degree in a scientific discipline is required.
• An advanced degree (eg, Masters, PhD, MD) preferred.
• At least 6 years of relevant pharmaceutical/scientific; at least 4 years of relevant medical writing experience is required.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
• English fluency required.
• Attention to detail.
• Able to function in a team environment.
• Strong project/time management skills.
• Strong project/process leadership skills.
• Able to resolve complex problems under supervision.Demonstrate learning agility.
• Able to build solid and productive relationships with cross-functional team members.

Responsabilités

• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Leading cross-functional document planning and review meetings. Interacting with cross-functional colleagues on document content and acting as a champion of medical writing processes and best practices.
• Will function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.
• Will be primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
• Coach or mentor of more junior staff on document planning, processes, and content.
• Active participant in or lead of process working groups.

Connaissances

Medical Writing

Regulatory Writing

Cross-functional collaboration

Project management

Communication

Team collaboration

Attention to detail

Problem solving

Formation

Bachelor's degree in a scientific discipline

Advanced degree preferred (Masters/PhD/MD)

Description du poste

Johnson & Johnson in Leiden, Netherlands seeks a Medical Writer III, Regulatory Medical Writing, to support global regulatory documents across multiple therapeutic areas within IDAR. Hybrid model with potential multi-country postings; case-by-case remote options.

The role emphasizes leading document planning, mentorship, and cross-functional collaboration to ensure timely, compliant submissions. Requires 6+ years in pharma writing and strong English communication.