Senior Manager/Associate Director Medical Writing, Immunology

7360-Janssen-Cilag Limited Legal Entity; High Wycombe; Hybrid; GBP 101,000 - 176,000; Full time

Job summary

A leading healthcare company is seeking a Senior Manager/Associate Director for Regulatory Medical Writing to join their team in High Wycombe. The ideal candidate will have extensive experience in pharmaceutical writing, strong leadership skills, and a proven track record in managing complex projects. This hybrid role involves leading writing teams and mentoring junior staff while ensuring compliance with regulatory standards. Competitive salary and benefits are offered.

Benefits

Performance-based compensation

Annual performance bonus

Company-sponsored benefit programs

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 writing teams independently and set objectives.
• Coordinate all types of clinical and regulatory documents.
• Supervise direct reports and provide performance feedback.

Skills

Leadership

Medical writing

Project management

Communication

Attention to detail

Regulatory knowledge

Education

University/college degree in a scientific discipline

Advanced degree (Masters, PhD, MD)

Job description

Senior Manager/Associate Director Medical Writing, Immunology

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. Work locations include High Wycombe, Buckinghamshire, United Kingdom.

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

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 our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).

Job responsibilities:

• Leading compound/submission/indication/disease area writing teams independently.
• Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
• Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
• Establishing and driving document timelines and strategies independently.
• Guiding or training cross-functional team members on processes and best practices.
• Proactively identifying and championing departmental process improvements.
• May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.
• Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
• Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.
• Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.

As a people manager:

• Supervising/managing and being accountable for direct reports.
• Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development.
• Regularly meeting 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.
• Ensuring direct report’s adherence to established policies, procedural documents, and templates.
• Participating 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 / Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (eg, 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 risks with mitigation strategies.
• Ability to liaise 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 management and project management skills; strong leadership and change management capabilities.
• Ability to delegate to junior writers and act as a change agent in a rapidly changing environment.

Notes:

• This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Apply to the postings that align with your location(s):
• United Kingdom - Requisition Number: R-035253
• Belgium, Netherlands - Requisition Number: R-035805
• Switzerland - Requisition Number: R-035807
• United States - Requisition Number: R-035808

For United States applicants:

The anticipated base pay range for this position is $137,000 to $235,750 (USD).

The Company maintains highly competitive, performance-based compensation programs. This position is eligible for an annual performance bonus. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in Company-sponsored benefit programs and retirement plans, with time off benefits including vacation, holidays, and other leave in accordance with local policy.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.