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Manager, Regulatory Medical Writing
Johnson & JohnsonManager, Regulatory Medical Writing at Johnson & Johnson developing treatments across X-TA. Leading projects and ensuring compliance with regulatory guidelines in a hybrid work setting.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in medical writing and project leadership within the pharmaceutical industry, with a strong ability to prepare clinical documents and guide teams effectively. Proficient in regulatory guidance and capable of interpreting complex medical information.
Highest-signal resume keywords
Medical Writing ExperienceProject Leadership SkillsRegulatory Guidance KnowledgeStatistical Information InterpretationTeam Coaching and Mentoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Document PreparationScientific Strategy DevelopmentProject ManagementProcess Improvement RecommendationsTherapeutic Area KnowledgeStatistical Information PresentationAttention to DetailLearning Agility
Soft Skills
Excellent Oral CommunicationExcellent Written CommunicationRelationship BuildingProblem Solving
Certifications & Qualifications
University/College DegreeMasters or PhD Preferred
Industry Keywords
Pharmaceutical ExperienceMedical WritingICH RequirementsSubmission Leadership
About the role
Key responsibilities & impact- Preparing and finalizing all types of clinical documents.
- Leading in a team environment.
- Working independently on assigned projects with respect to content, scientific strategy, timing, scheduling, and tracking.
- Setting objectives for others on team projects.
- Guiding or training team members on processes and best practices.
- Leading project-level writing teams.
- Providing recommendations for departmental process improvements.
- Actively participating in medical writing and cross-functional meetings.
- Coaching or mentoring junior staff and overseeing the work of others.
Requirements
What you’ll need- 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.
- Submission leadership experience preferred.
- Experience of multiple therapeutic areas preferred.
- Attention to detail.
- Excellent oral and written communication skills.
- English fluency required.
- Expert project/time management skills.
- Strong project/process leadership skills.
- Ability to interpret, summarize, and present statistical and medical information.
- Able to resolve complex problems independently.
- Demonstrate learning agility.
- Ability to build and maintain positive relationships with team members.
- Solid knowledge/application of regulatory guidance documents such as ICH requirements.
- Ability to commute to site.
Benefits
Comp & perks- We offer a competitive salary and extensive benefits package.
- Annual bonus with set target (% of pay) depending on pay grade / location, determined by performance.
- 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 subject to the terms of their respective plans.