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Medical Writer III
Johnson & JohnsonMedical Writer III developing regulatory documents and leading cross-functional teams for Innovative Medicine at Johnson & Johnson. Requires 6+ years of experience, ideally in immunology.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory medical writing, including the creation and coordination of clinical documents such as CSRs, protocols, and regulatory responses. Proven ability to lead cross-functional teams, mentor junior staff, and manage project timelines effectively.
Highest-signal resume keywords
Regulatory Medical WritingClinical Document CoordinationImmunology Therapeutic Area ExperienceProject ManagementMentoring Junior Staff
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study Reports (CSRs)ProtocolsRegulatory ResponsesSummary DocumentsRisk Management Plans (RMPs)Document PlanningMetrics Database ManagementProject TrackingTime Reporting
Soft Skills
Leadership SkillsCollaborationNegotiationAssertivenessInitiative
Industry Keywords
Pharmaceutical IndustryScientific DisciplineCross-Functional TeamsGlobal CollaborationTime Zone Flexibility
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.
- 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).
Benefits
Comp & perks- an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
- vacation days
- parental leave for a minimum of 12 weeks
- bereavement leave
- caregiver leave
- volunteer leave
- well-being reimbursement
- programs for financial, physical and mental health
- service anniversary and recognition awards
- participation in several insurance plans for employees - and in some location’s eligible dependents - subject to the terms of their respective plans.