Immunology Regulatory Medical Writing Manager

360Pharma; Netherlands; On-site; EUR 110,000 - 150,000; Full time

Job summary

360Pharma is seeking a Manager, Regulatory Medical Writing focused on Immunology. You will lead a team, shape scientific strategy, and ensure high-quality clinical writing across projects.

The role requires overseeing timelines, coordinating cross-functional activities, and mentoring staff in a fast-paced regulatory environment. The position emphasizes collaboration with clinical, regulatory, and medical affairs teams, adherence to ICH guidelines, and proactive process improvements to advance

Qualifications

• Minimum of 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required.
• 2 years of people management experience is preferred.
• Attention to detail and strong cross-functional communication skills are essential.
• Expert project and time management skills with leadership capabilities.
• Solid knowledge of regulatory guidance documents such as ICH requirements.

Responsibilities

• Prepare and finalize all types of clinical documents.
• Lead in a team environment with independence and strategic input on content, timing, and tracking.
• Set objectives for others on team projects and lead process working groups.
• Coach cross-functional team members on processes and best practices.
• May lead project-level writing teams and submissions.
• Recommend departmental process improvements for efficiency.
• Act as primary contact for medical writing activities for the clinical team when leading a program.
• Participate actively in medical writing and cross-functional meetings.
• Maintain knowledge of industry, company, and regulatory guidelines.
• Mentor junior staff and oversee contractors and document specialists.
• Represent Medical Writing in industry standards groups as needed.

Skills

Attention to detail

Oral and written communication

Project management

Leadership

Cross-functional collaboration

Regulatory knowledge

Problem solving

Learning agility

Team management

Education

University/college degree

Masters or PhD

Job description

360Pharma is seeking a Manager, Regulatory Medical Writing focused on Immunology. You will lead a team, shape scientific strategy, and ensure high-quality clinical writing across projects.

The role requires overseeing timelines, coordinating cross-functional activities, and mentoring staff in a fast-paced regulatory environment. The position emphasizes collaboration with clinical, regulatory, and medical affairs teams, adherence to ICH guidelines, and proactive process improvements to advance