Associate Director, Medical Writing

Johnson & Johnson Pennsylvania , AL 35023

Posted 2 months ago

Integrated Data Analytics and Reporting (IDAR)

Position Title: Associate Director Medical Writing

Position Summary:

  • 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, Masters, PhD, 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.

  • Identifies and resolves problems related to 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 change agent and adapt to rapidly changing organizational & business challenges.

At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Primary Location

Belgium-Antwerp-Beerse-

Other Locations

North America-United States-New Jersey, North America-United States-Pennsylvania, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

R&D

Requisition ID

2206036894W

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Associate Director, Medical Writing

Johnson & Johnson