Manager / Associate Director Medical Writing, Immunology

Johnson & Johnson; England; Hybrid; GBP 103,000 - 179,000; Full time

Job summary

A global healthcare company seeks a Senior Manager in Regulatory Medical Writing to support its Immunology area. The role involves leading writing teams, coordinating clinical documents, and managing direct reports. With at least 10 years in the pharmaceutical industry, including 8 years in medical writing, the ideal candidate has strong leadership skills. This position offers competitive compensation, including a bonus and comprehensive benefits, along with a hybrid working model. Remote options available on a case-by-case basis.

Benefits

Medical insurance

Dental insurance

Vision insurance

Life insurance

Retirement and savings plans

Qualifications

• At least 10 years of relevant pharmaceutical/scientific experience.
• At least 8 years of relevant clinical/regulatory medical writing experience.
• At least 2 years of direct people-management experience.

Responsibilities

• Lead compound and regulatory writing team independently.
• Write and coordinate clinical and regulatory documents.
• Guide and train cross-functional team members.

Skills

Regulatory guidance interpretation

Excellent communication skills

Project management

Leadership

Process improvement

Education

University degree in a scientific discipline

Masters, PhD, or MD preferred

Job description

We are searching for the best talent for a Senior Manager / Associate Director, Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area. The position can be located at any of the following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House / Raritan / Titusville (East Coast US). Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case‑by‑case basis and if approved by the company.

Responsibilities

• Lead compound / submission / indication / disease area writing teams independently.
• Lead or set objectives for team projects and tasks, e.g., lead Medical Writing process working groups or Communities of Practice.
• Write or coordinate all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
• Establish and drive document timelines and strategies independently.
• Guide or train cross‑functional team members on processes and best practices.
• Proactively identify and champion departmental process improvements.
• May lead cross‑functional, cross‑therapy area, or cross‑J&J process improvement initiatives.
• Lead discussions in MW and cross‑functional meetings as appropriate (e.g., submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
• Maintain and disseminate knowledge of industry, company, and regulatory guidelines.
• Interact with senior cross‑functional colleagues and external partners to strengthen coordination between departments.

People Manager Responsibilities

• Supervise/manage and be accountable for direct reports.
• Set objectives and agree on goals for direct reports, providing performance oversight, including feedback on performance and development.
• Regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
• Coaching or mentoring more junior writers on document planning, processes, content, and providing peer review as needed.
• Ensure direct reports' adherence to established policies, procedural documents, and templates.
• Participate in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end‑of‑year performance reviews, and compensation planning.

Qualifications

• A university/college degree in a scientific discipline is required; an advanced degree (Masters, PhD, MD) is preferred.
• At least 10 years of relevant pharmaceutical/scientific experience.
• At least 8 years of relevant clinical/regulatory medical writing experience.
• At least 2 years of direct people-management experience.
• Experience in project management and process improvement.
• Advanced knowledge and application of regulatory guidance such as ICH requirements.
• Ability to interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
• Resolves complex problems independently and proactively identifies potential risks with mitigation strategies.
• Ability to serve as the liaison between team members and senior leadership within a therapy area.
• Ability to build and maintain solid relationships with cross‑functional team members.
• Excellent oral and written communication skills; attention to detail; expert time and project management skills; strong leadership and change management abilities.
• Ability to delegate responsibility to junior writers and to act with integrity and adherence to CREDO values.

Compensation & Benefits

The anticipated base pay range for this position is $137,000 to $235,750 (USD). The company offers competitive, performance‑based compensation, including an annual bonus at the company’s discretion. Benefits include medical, dental, vision, life insurance, disability, and group legal insurance, plus retirement and savings plans. Time off includes vacation, sick time, holidays, and work/personal time, with details per location.