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Purpose: Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team is recruiting for a Manager, Regulatory Medical, Immunology.  This position will support our Immunology therapeutic area. Are you ready to join our team? Then please read further!

You will be responsible for:

• Prepare and finalize all types of clinical documents.
• Lead in a team environment. Work with a high level of independence and take a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
• Lead or set objectives for others on team projects and tasks, eg, lead process working groups.
• Guide or train cross-functional team members on processes and best practices.
• May lead project-level/submission/indication writing teams.
• Proactively provide recommendations for departmental process improvements.
• If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
• Actively participate in medical writing and cross-functional meetings.
• Maintain knowledge of industry, company, and regulatory guidelines.
• Coach or mentor more junior staff on document planning, processes, content, and provide peer review as needed; may oversee the work of other medical writers, external contractors, and document specialists supporting a project.
• May interact with senior cross-functional colleagues to strengthen coordination between departments.
• May represent Medical Writing department in industry standards working groups.
• Manage direct reports in Medical Writing. Set objectives for individual team members. Regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
• Make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal‐setting, and performance discussions.

Qualifications/Requirements:

Education: 

Minimum of University/college degree required. Masters or PhD preferred. 

Experience and Skills:

• At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required.
• 2 years of people management experience is required.
• Attention to detail.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
• Able to resolve complex problems independently.
• Demonstrate learning agility.
• Able to build and maintain solid and positive relationships with cross‐functional team members.
• Solid knowledge and application of regulatory guidance documents such as ICH requirements.

The expected pay range for this position is $117,000 to $201,250.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period10 days
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year

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

This job posting is anticipated to close on May 1, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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

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The anticipated base pay range for this position is :

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