Associate Director, Regulatory Medical Writing

Company: Disability Solutions
Location: Spring House
Posted on: February 1, 2025

Job Description:

We are recruiting for an Associate Director to join the Regulatory Medical Writing team to support the Oncology therapeutic area. The position may be located in Spring House, PA or Raritan or Titusville, NJ, in the US; High Wycombe in the UK; or other global locations. Remote work options may also be considered on a case-by-case basis and if approved by the business.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. \rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.\rWe know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.\rAt Johnson & Johnson, we all belong.\rAre you ready to join our team? Then please read further!\rKey ResponsibilitiesThis position will lead medical writing (MW) activities in the Hematologic Malignancies disease area, and will lead a team of internal writers who can be deployed across J&J Oncology programs. This role will report directly to the Hematologic Malignancies Disease Area Head, Regulatory Medical Writing, Oncology.\r

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• Is the primary point of contact for MW activities for the cross-functional team in the disease area.
• Writes or coordinates all types of clinical and regulatory documents, taking a proactive lead role in driving 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-therapeutic area, or cross-J&J process improvement initiatives.
• Leads discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, study team meetings, clinical team meetings).
• Maintains and disseminates knowledge of industry, company, and regulatory guidelines.
• Interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.\r\r\rAs a people manager:
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  • Leads and is accountable for direct reports.
  • Ensures team members adhere to established policies, procedural documents, and templates.
  • Participates in hiring, onboarding, conducting career and talent development discussions, goal-setting, performance reviews, and compensation planning.\r\r

Keywords: Disability Solutions, East Orange , Associate Director, Regulatory Medical Writing, Advertising , Spring House, New Jersey