Manager, Medical Writing, Immunology

360Pharma; Netherlands; Vor Ort; EUR 110.000 - 150.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Attention to detail

Oral and written communication

Project management

Leadership

Cross-functional collaboration

Regulatory knowledge

Problem solving

Learning agility

Team management

Ausbildung

University/college degree

Masters or PhD

Jobbeschreibung

We are searching for the best talent for Manager, Medical Writing, Immunology.

Purpose

Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team is recruiting for a Manager, Regulatory Medical, Immunology. This position will support our Immunology therapeutic area. Are you ready to join our team? Then please read further!

You will be responsible for:

• Prepare and finalize all types of clinical documents.
• Lead in a team environment. Work with a high level of independence and take a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
• Lead or set objectives for others on team projects and tasks, eg, lead process working groups.
• Guide or train cross-functional team members on processes and best practices.
• May lead project-level/submission/indication writing teams.
• Proactively provide recommendations for departmental process improvements.
• If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
• Actively participate in medical writing and cross-functional meetings.
• Maintain knowledge of industry, company, and regulatory guidelines.
• Coach or mentor more junior staff on document planning, processes, content, and provide peer review as needed; may oversee the work of other medical writers, external contractors, and document specialists supporting a project.
• May interact with senior cross-functional colleagues to strengthen coordination between departments.
• May represent Medical Writing department in industry standards working groups.
• Manage direct reports in Medical Writing. Set objectives for individual team members. Regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolvedMake decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal‑setting, and performance discussions.

Qualifications/Requirements

Education

• Minimum of University/college degree required. Masters or PhD preferred.

Experience and Skills

• At least 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.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
• Able to resolve complex problems independently.
• Demonstrate learning agility.
• Able to build and maintain solid and positive relationships with cross‑functional team members.
• Solid knowledge and application of regulatory guidance documents such as ICH requirements.

Preferred Skills

• Analytics Insights, Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Copy Editing, Cross-Functional Collaboration, Developing Others, Inclusive Leadership, Industry Analysis, Leadership, Medical Affairs, Medical Communications, Performance Measurement, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Team Management