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, e.g., 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.

Required Skills

• Analytics Insights
• Business Writing
• Clinical Research and Regulations
• Clinical Trials Operations
• Copy Editing
• Cross-Functional Collaboration
• Developing Others
• Inclusive Leadership
• Industry Analysis
• Leadership
• Medical Affairs
• Medical Communications
• Performance Measurement
• Quality Validation
• Standard Operating Procedure (SOP)
• Tactical Planning
• Team Management

Preferred Skills

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson

Global healthcare innovation spanning medicines, medical devices and life saving technologies

New Brunswick Pharma 1000+

Shape the future of healthcare by working on innovations that genuinely change lives, from medicines that unlock new cancer treatments to devices that make surgery safer. Your work will reach millions of patients who need breakthroughs most.

Click to learn more

Shape the future of healthcare by working on innovations that genuinely change lives, from medicines that unlock new cancer treatments to devices that make surgery safer. Your work will reach millions of patients who need breakthroughs most.

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Manager, Medical Writing, Immunology

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