Senior Manager/Associate Director Medical Writing, Immunology

Johnson and Johnson; High Wycombe; Hybrid; GBP 137,000 - 236,000; Full time

Job summary

A leading global healthcare company is seeking a Senior Manager/Associate Director of Regulatory Medical Writing in High Wycombe. This role involves leading writing teams, managing projects, and ensuring the quality of regulatory documents. The ideal candidate has at least 10 years of relevant experience, with a strong background in medical writing and leadership. Hybrid working is preferred.

Benefits

Competitive base salary

Performance-based bonuses

Comprehensive health insurance

Generous time off policies

Qualifications

• Minimum 10 years of relevant pharmaceutical/scientific experience.
• At least 8 years of relevant clinical/regulatory medical writing experience.
• Experience in people management for 2+ years.

Responsibilities

• Leading writing teams in regulatory medical documentation.
• Setting objectives for team projects.
• Interacting with internal and external partners.

Skills

Leadership

Project management

Regulatory knowledge

Communication skills

Problem-solving

Education

Advanced degree in a scientific discipline (Masters, PhD, MD)

Job description

Overview

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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

Job Details

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).

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

• 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 goals; providing performance oversight and development; regular check-ins; coaching or mentoring junior writers; ensuring adherence to policies and templates; participating in hiring, onboarding, and performance discussions.

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 potential risks with mitigation strategies.
• Ability to liaison between team members and senior leadership within a therapy area; build and maintain cross-functional relationships.
• Excellent oral and written communication skills; attention to detail; expert time and project management skills; strong leadership, negotiation, and change management abilities.
• Ability to delegate to junior writers; lead by example; uphold CREDO values; act as a change agent in a dynamic environment.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred 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

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Compensation & Benefits (United States)

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

The Company offers competitive, performance-based compensation programs and an annual performance bonus in accordance with governing plans. Bonuses are discretionary and based on individual and company performance.

Employee benefits may include medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Eligibility for retirement (pension) and savings plans (401(k)) varies by location.

Time off benefits include: Vacation up to 120 hours/year; Sick time up to 40 hours/year (Washington state: up to 56 hours); Holiday pay up to 13 days/year; Work, Personal and Family Time up to 40 hours/year.

For general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for benefits in accordance with their local market.

EEO Statement

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.

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