Johnson & Johnson
- Able to function as a lead writer on any compound independently.
- Leads in setting functional tactics/strategy.
- Leads TA-level strategy (eg, submission team, global program team, clinical team).
- Can represent 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 therapeutic areas (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, cross-J&J initiative/collaboration (eg, leadership of Community of Practice)
- Larger organizational responsibility (eg, manage a subset of TA org)
As a people manager:
- Manages a team of internal medical writers (direct reports).
- Accountable for the quality of deliverables and for compliance of direct reports.
- Actively participates in resource management and hiring decisions.
- 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 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.
- Responsible for establishing and driving document timelines and strategies independently.
- Guides or trains cross-functional team members on processes, best practices; coaches or mentors more junior writers.
- Proactively identifies and champions departmental process improvements.
- May develop and present best practices to external audiences.
- May lead cross-functional/cross-TA, cross-J&J process improvement initiatives.
- Leads discussions in Medical Writing 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.
- Leads process working groups. May serve as Sponsor for internal initiatives/Communities of Practice.
- 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 medical writing in industry standards working groups.
- Able to function as a lead writer on any compound (or submissions, indications or disease areas]) under supervision: is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
- As a people manager:
- Supervises/manages direct reports. Sets objectives for direct reports.
- Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
- 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.
- Performance oversight, feedback, and development, as well as accountability for direct reports.
- Ensures staff's adherence to established policies, procedural documents, and templates.
- 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, Janssen R&D Procurement, and External Alliances. 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 and others as assigned.
Education and Experience Requirements
- A university/college degree is required. An advanced degree (eg, Master's, Ph.D., MD) is preferred.
- At least 12 years of relevant pharmaceutical/scientific experience is required.
- At least 10 years of relevant clinical/regulatory medical writing experience is required.
- At least 2 years of people management experience is required.
- Experience in project management and process improvement 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 them.
- Identifies and resolves problems related to the development and implementation of new service offerings/deliverables.
- May 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.
- Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
- Ability to delegate responsibility to junior writers.
- Strong people management skills.
- Ability to lead by example, stay focused and positive, and act with integrity.
- Strong influencing skills on teams and individually.
- Ability to internalize and teach CREDO behaviors.
- Ability to act as a change agent and adapt to rapidly changing organizational & business challenges.