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Job Description:

Position Summary:

• Able to function as a lead writer on any compound independently.
• Leads in setting functional tactics/strategy.
• Leads project-level strategy (eg, submission team, global program team, clinical team).
• May represent therapeutic area (TA) head at high-level and cross-functional TA meetings and has some independent decision-making authority.
• Able to write and coordinate complex documents within and across TAs independently.
• Contributes to and champions internal standards, regulatory, and publishing guidelines.
• Contributes to and champions the improvement of internal systems, tools, and processes.
• Able to lead process working groups.
• Able to oversee the work of external contractors.
• May have additional major responsibility with supervision:
• Cross-functional, cross-TA, or cross-J& J initiative/collaboration.
• Larger organizational responsibility (eg, manage a subset of TA).
• If a people manager:
• Manages a team of internal medical writers (direct reports).
• Accountable for the quality of deliverables and compliance of direct reports.
• Actively participates in resource management and hiring decisions.

Principal Responsibilities:

• Able to lead compound/submission/indication/disease area writing teams independently.
• Directly leads or sets objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
• Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
• Establishes and drives document timelines and strategies independently.
• Guides or trains cross-functional team members on processes and best practices; coaches or mentors more junior writers.
• Proactively identifies and champions departmental process improvements.
• May develop and present best practices or innovations to internal or external audiences.
• May lead cross-functional, cross-TA, or cross-J& J process improvement initiatives.
• Leads discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
• Maintains and disseminates knowledge of industry, company, and regulatory guidelines.
• Completes all time reporting, training, metrics database, and project tracking (functional planning) updates as required in relevant company systems.
• Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed.
• If applicable, has lead MW responsibilities for providing guidance on deliverables, content, etc.
• Interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.
• May represent MW in industry standards working groups.
• As a MW lead, is the primary point of contact for MW activities for the cross-functional team (eg, clinical).
• If a people manager:
• Supervises/manages and is accountable for direct reports.
• Sets objectives and agrees on goals for direct reports. Provides performance oversight, including feedback on performance and development.
• Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
• Ensures direct report’s adherence to established policies, procedural documents, and templates.
• Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.

• Principal Relationships:

• Internal: MW senior leadership team (SLT), manager, peer writers, cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of documents, Human Resources, Finance, Information Technologies, Procurement, and Partnerships. May interact with senior external colleagues with coordination between departments.
• External: May oversee day-to-day project-related work of contractors or external service providers as needed. May collaborate with external partner company staff on codeveloped compounds.
• Supervision (direct): Direct reports (if applicable), and others as assigned.

Education and Experience Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
• At least 10 years of relevant pharmaceutical/scientific experience is required.
• At least 8 years of relevant clinical/regulatory medical writing experience is required.
• Experience in project management and process improvement is required.
• If a people manager: at least 2 years of people management experience is required.

Other:

• Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
• Resolves complex problems independently.
• Advanced knowledge and application of regulatory guidance documents such as ICH requirements
• Interacts with senior cross-functional colleagues and external partners, often requiring coordination across multiple functions and groups.
• Proactively identifies potential risks and develops strategies to mitigate.
• Identifies and resolves problems related to development and implementation of new service offerings/deliverables.
• Ability to serve as the liaison between team members and senior leadership within a TA.
• Excellent oral and written communication skills.
• Attention to detail.
• Expert time management for self, direct reports (if applicable), and teams.
• Ability to build and maintain solid and productive relationships with cross-functional team members.
• Expert project management skills, expert project/process leadership.
• Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
• Ability to delegate responsibility to junior writers.
• Ability to lead by example, stay focused and positive, and act with integrity.
• Ability to internalize and teach CREDO behaviors.
• Ability to act as change agent and adapt to rapidly changing organizational & business challenges.
• If a people manager: Strong people management skills.

＜ For Internal Applicants＞

• If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.
• For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.