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QUALIFICATIONS / 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.
• 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.

PURPOSE:

• 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.

YOU WILL BE RESPONSIBLE FOR:

• 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.