Medical Writer III

Johnson & Johnson

Medical Writer III at Johnson & Johnson developing clinical and regulatory documents. Collaborating with cross-functional teams to ensure compliance and quality standards in pharmaceutical writing.

Posted 7/25/2026full-timeHorsham • New Jersey, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $109,000 - $174,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory medical writing, including the ability to produce high-quality clinical documents such as CSRs and protocols. Strong leadership and mentoring skills are essential for guiding cross-functional teams and junior staff in document planning and execution.

Highest-signal resume keywords

Regulatory Medical WritingClinical Document DevelopmentImmunology Therapeutic Area ExperienceProject ManagementMentoring and Coaching

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Reports (CSRs)Investigational Brochures (IBs)Regulatory ResponsesDocument PlanningStatistical InterpretationCompound Lead ExperienceSubmission Lead Experience

Soft Skills

LeadershipAttention to DetailProblem SolvingCollaborationTime Management

Tools & Technologies

Metrics DatabaseProject Tracking Systems

Industry Keywords

Pharmaceutical IndustryScientific DisciplineCross-Functional CollaborationGlobal TeamsLearning Agility

About the role

Key responsibilities & impact

Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
Leading cross-functional (eg, with clinical team) document planning and review meetings.
Interacting with cross-functional colleagues on document content and champions MW processes and best practices.
Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
Completing all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.
Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
Coaching or mentoring more junior staff on document planning, processes, and content.
Provides peer review as needed.
Actively participating in or leads process working groups.

Requirements

What you’ll need

Minimum of university/college degree in a scientific discipline is required.
An advanced degree (eg, Masters, PhD, MD) is preferred.
At least 6 years of relevant pharmaceutical/scientific industry experience including at least 4 years of regulatory medical writing experience.
Immunology therapeutic area experience is strongly preferred.
Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision.
Compound lead and/or submission lead experience is preferred.
Proficiency in written and spoken English is essential, along with the ability to collaborate with global teams and stakeholders across time zones, requiring some flexibility in your daily routine.
Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
Resolves complex problems under supervision.
Able to resolve complex problems under supervision.
Demonstrate learning agility (self-development) and mentoring competency (development of others).
Strong attention to detail.

Benefits

Comp & perks

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)).
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year