Associate Director, X-TA Regulatory Medical Writing

At Johnson & Johnson Innovative Medicine, we focus on helping people live full and healthy lives. We seek to develop medicines of tomorrow and champion patients every step of the way. This role supports one or more therapeutic areas within the X-TA Regulatory Medical Writing area in our Integrated Data Analytics & Reporting (IDAR) business.

This position is open globally and may be in Europe (e.g., United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy) as well as North America (e.g., Spring House, PA; Raritan, NJ; Titusville, NJ). Candidates from any location may apply.

Work arrangement: hybrid (3 days in office and 2 remote) OR remote in all listed countries. Remote options may be considered on a case-by-case basis and if approved by the Company.

You Will Be Responsible For

• Leading compound/submission/indication/disease area writing teams independently.
• May have additional major responsibility with supervision.
• Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
• Larger organizational responsibility (e.g., manage a subset of TA).
• Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy, with a high level of independence and leadership on timing, scheduling, and tracking.
• Leading program-level/submission writing teams independently.
• Directly leading or setting objectives for others on team projects and tasks.
• Guiding or training cross-functional team members on processes and best practices; coaching or mentoring more junior writers.
• Proactively identifying and championing Medical Writing process improvements, internal standards, regulatory and publishing guidelines, internal systems, tools, and processes.
• Leading cross-functional/cross-TA and cross-J&J process improvement initiatives or other large process working groups.
• Developing, maintaining and disseminating 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; lead as a senior writer on compounds independently; lead discussions in Medical Writing and cross-functional meetings; coordinate with senior cross-functional colleagues and external partners; oversee external contractors when applicable.
• As a people manager: manage direct reports in Medical Writing; set objectives for team members; ensure development and accountabilities; ensure adherence to policies and templates; participate in hiring decisions, onboarding, and performance discussions.

Qualifications / Requirements

• University/college degree in a scientific discipline is required; Masters or PhD preferred.
• At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of Medical Writing experience required.
• If a people manager, at least 2 years of people management experience.
• Multiple therapeutic area experience preferred.
• Strong attention to detail and excellent oral and written communication in English.
• Expert project management and process-improvement leadership.
• Strong leadership skills (influencing, negotiating, initiative, conflict management, change management) and people management capabilities.
• Ability to delegate to junior writers and collaborate 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 document types independently.

Note: This role is available across multiple countries and may be posted under different requisition numbers. When applying, focus on the country/countries that align with your location.

Locations and Hiring Notes

United Kingdom; Europe (BE/FR/DE/IRE/IT/NL/ES); United States (East Coast). Requisition numbers vary by country. Applications may be submitted to multiple postings as a single submission.

For United States Applicants, the anticipated base pay range is $137,000 to $235,750 (USD). The role may include eligibility for an annual performance bonus. Benefits may include medical, dental, vision, life insurance, disability coverage, and retirement plans, in addition to paid time off benefits as applicable by location.

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.