Senior Manager, Reg Medical Writing

6 days ago

Spring House, United States Disability Solutions Full time
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.

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Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina.

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Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team is recruiting for a Senior Manager. This position will support our immunology therapeutic area. The position may be located in Spring House, PA; Raritan or Titusville, NJ in the US; Beerse, Belgium; High Wycombe, UK; Switzerland; and Canada. Remote work options may also be considered on a case-by-case basis and if approved by the business. Are you ready to join our team? Then please read further

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Key Responsibilities:

This position will manage a pool of internal writers and will lead early development writing projects. The successful candidate:
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  • 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.
  • Is the primary point of contact for MW activities in early development for the cross-functional team (eg, nonclinical, clinical).
  • 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.
  • 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, 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.
  • Interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.
  • May represent MW in industry standards working groups.
  • As 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 and onboarding.
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