Associate Director, Medical Writing

Johnson & Johnson
Published
June 23, 2022
Location
United States
Category
Other  
Job Type
Work Setting
In-office

Description

  • 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.

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 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.

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, 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.

Qualifications

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.

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 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.
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