Manager, Medical Writing, Immunology

Johnson & Johnson

Manager in Medical Writing for Immunology at Johnson & Johnson, developing transformational medicines while leading a regulatory writing team.

Posted 7/25/2026full-timeSpring House • Pennsylvania • 🇺🇸 United StatesSeniorLead💰 $117,000 - $201,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in medical writing and project management within the pharmaceutical industry, with a strong focus on regulatory compliance and team leadership. Capable of mentoring junior staff and driving process improvements while maintaining high standards of quality and accuracy in clinical documentation.

Highest-signal resume keywords

Medical Writing ExperienceProject Management SkillsPeople Management ExperienceRegulatory Guidance KnowledgeCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Document PreparationScientific Strategy DevelopmentStatistical Information PresentationProcess Improvement RecommendationsDocument PlanningPeer ReviewContent SummarizationProject LeadershipObjective SettingPerformance Management

Soft Skills

Attention to DetailExcellent Communication SkillsProblem-Solving AbilityLearning AgilityRelationship Building

Certifications & Qualifications

University/College DegreeMasters or PhD Preferred

Industry Keywords

Pharmaceutical ExperienceICH RequirementsMedical Writing StandardsCross-Functional TeamworkTeam Leadership

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Minimum of University/college degree required
Masters or PhD preferred
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

Benefits

Comp & perks

medical, dental, vision, life insurance
short and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
annual performance bonus
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 period
volunteer leave – 32 hours per calendar year
military spouse time-off – 80 hours per calendar year