Senior Medical Writer – Regulatory (Hybrid)

7266-Janssen Biologics B.V. Legal Entity; Amsterdam; Hybride; EUR 64 000 - 118 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Career development opportunities

Flexible working environment

Résumé du poste

Johnson & Johnson in the Netherlands is seeking a Medical Writer III, Regulatory Medical Writing to support across key therapeutic areas within the Integrated Data Analytics & Reporting (IDAR) business. The position may be located Maidenhead, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; or Beerse, Belgium.

Hybrid (3 days onsite weekly) with remote options considered on a case-by-case basis. The role requires a scientific degree, 6+ years in pharma writing, and strong English

Qualifications

• A university/college degree in a scientific discipline is required.
• An advanced degree (Masters, PhD, or MD) is preferred.
• At least 6 years of relevant pharmaceutical/scientific experience; at least 4 years in medical writing is required.
• Excellent oral and written communication skills; English fluency required.

Responsabilités

• Writing or coordinating clinical and regulatory documents (CSRs, IBs, protocols, RMPs, regulatory responses).
• Leading cross-functional document planning and review meetings.
• Interacting with cross-functional colleagues and championing medical writing processes.
• Setting document timelines and strategies with mentorship from management.
• Leading writer on compounds or submissions under supervision.
• Serving as primary contact for medical writing activities within cross-functional teams.
• Coaching junior staff on document planning, processes, and content.
• Providing peer review as needed.
• Active participant in or lead of process working groups.

Connaissances

Medical Writing

Project Management

Regulatory Writing

English fluency

Formation

Bachelor's degree in a scientific discipline

Advanced degree (Masters/PhD/MD) preferred

Description du poste

Johnson & Johnson in the Netherlands is seeking a Medical Writer III, Regulatory Medical Writing to support across key therapeutic areas within the Integrated Data Analytics & Reporting (IDAR) business. The position may be located Maidenhead, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; or Beerse, Belgium.

Hybrid (3 days onsite weekly) with remote options considered on a case-by-case basis. The role requires a scientific degree, 6+ years in pharma writing, and strong English