Associate Director, X-TA Regulatory Medical Writing in High Wycombe

Location: High Wycombe, United Kingdom; Beerse, Belgium; Leiden, Netherlands; Spring House, PA, United States; Raritan, NJ, United States; Titusville, NJ, United States.

Overview: Associate Director of Regulatory Medical Writing within the Integrated Data Analytics & Reporting (IDAR) business, supporting one or more therapeutic areas in the X-TA Regulatory Medical Writing area. This hybrid role requires 3 days in office and 2 days remote with flexible remote options on a case‑by‑case basis.

Responsibilities:

• Lead compound/submission/indication/disease area writing teams independently.
• Serve as a senior member of cross‑functional, cross‑TA or cross‑J&J initiatives and collaborations.
• Manage a subset of therapeutic areas, providing broader organizational responsibility.
• Prepare and finalize all types of clinical documents, taking proactive or lead roles in content, scientific strategy, timing, scheduling, and tracking.
• Lead program‑level/submission writing teams independently.
• Directly lead or set objectives for others on team projects and tasks.
• Guide or train cross‑functional team members on processes, best practices; coach or mentor more junior writers.
• Proactively identify, contribute to and champion Medical Writing process improvements, internal standards, regulatory and publishing guidelines, internal systems, tools and processes.
• Lead cross‑functional/cross‑TA, cross‑J&J process improvement initiatives or large working groups.
• Develop, maintain and disseminate knowledge of industry, company and regulatory guidelines to internal and external audiences.

If a lead writer for a program:

• Primary point of contact and champion for Medical Writing activities for the clinical team.
• Plan and lead the writing group for the assigned program.
• Function as a lead writer on any compound independently.
• Lead discussions in Medical Writing and cross‑functional meetings as appropriate.
• Interact with senior cross‑functional colleagues and external partners to strengthen coordination between departments.
• Oversee the work of external contractors.

As a people manager:

• Manage direct reports in Medical Writing.
• Set objectives for individual team members and hold regular meetings to ensure appropriate development, projects, assignments, and issue resolution.
• Ensure direct reports adhere to established policies, procedural documents, and templates.
• Make decisions on hiring staff, onboarding, career and talent development discussions, goal setting and performance discussions.

Qualifications / Requirements:

• University/college degree in a scientific discipline (Masters or PhD preferred).
• At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience.
• At least 2 years of people management experience.
• Multiple therapeutic area experience preferred.
• Strong attention to detail.
• Strong oral and written communication skills; fluent written and spoken English.
• Expert project management and process improvement leadership.
• Expert leadership skills (influencing, negotiating, assertiveness, initiative, conflict management, change management).
• Strong people management skills.
• Ability to delegate responsibility to junior writers.
• Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
• Ability to interpret, summarize and present statistical and medical information to ensure quality and accuracy of content in complex documents independently.

Compensation (United States): Base pay range: $137,000 to $235,750 USD (annual). Eligible for an annual performance bonus and Company‑sponsored benefits including medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Eligible for the consolidated retirement plan (401(k)).

Time Off Benefits:

• Vacation – up to 120 hours per calendar year.
• Sick time – up to 40 hours per calendar year; up to 56 hours per calendar year for employees residing in Washington State.
• Holiday pay, including Floating Holidays – up to 13 days per calendar year.
• Work, Personal and Family Time – up to 40 hours per calendar year.

Required Skills:

• Medical Writing
• People Leadership
• Project Management
• Regulatory Writing
• Solid Scientific Background

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
• SOP
• Succession Planning
• Tactical Planning
• Team Management

This role is available across multiple countries and may be posted under different requisition numbers. Candidates applying in the United Kingdom, Belgium/Netherlands, or United States will be considered for the respective local compensation and benefits. The United States salary range is specified above; overseas candidates will receive local market compensation.