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J&J Family of Companies Director, Lung Cancer Institute Regulatory Medical Writing in Boston, Massachusetts

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Director-level position to join the Medical Writing team to support its Lung Cancer Institute (LCI). Preferably, the position would be located in Raritan or Titusville, NJ, Chesterbrook, Horsham or Spring House, PA, or Boston MA. Remote work options may be considered, on a case-by-case basis and if approved by the Company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com (file:///C:/Users/jamie%20yacco/AppData/Local/Microsoft/Windows/Temporary%20Internet%20Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Key Responsibilities:

  • Prepare and finalize all types of clinical documents supporting the LCI, taking a proactive or lead role in terms of content and scientific strategy. Work with a high level of independence and take a lead role on assigned projects with respect to timing, scheduling, tracking, and management.

  • Able to lead LCI program-level/submission/indication writing teams independently.

  • Directly lead or set objectives for others on LCI team projects and tasks.

  • Guide or train cross ‐ functional team members on processes, best practices; coach or mentor more junior writers.

  • Proactively identify and champion Medical Writing process improvements.

  • Able to develop and present best practices to external audiences.

  • Able to lead cross ‐ functional/cross ‐ LCI, cross ‐ J&J process improvement initiatives, or other process working group.

  • Able to represent LCI Medical Writing interests with decision-making authority in R&D business organization with guidance from LCI and sector partners or Global Head of Regulatory Medical Writing.

  • Responsible for providing guidance on LCI deliverables and content.

  • Lead discussions in Medical Writing and cross ‐ functional meetings as appropriate.

  • Maintain and disseminate knowledge of industry, company, and regulatory guidelines.

  • Interact with senior cross ‐ functional colleagues and external partners to strengthen coordination between departments.

  • Able to represent Medical Writing in industry standards working groups.

  • Manage work of contract writers supporting LCI Medical Writing. Regularly meet with contract writers to ensure appropriate support on assignments (e.g., training, coaching, resources, etc.) and to resolve issues as they arise.

  • Able to make decision on hiring and onboarding new contract writers.

Qualifications

Required:

  • Bachelor’s degree is the minimum educational requirement.

  • 14+ years of relevant pharmaceutical/scientific experience

  • 12+ years of relevant medical writing experience

  • Strong oral and written communication skills.

  • Expert project management skills, expert project/process improvement leadership.

  • Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Expert people management skills.

  • Ability to delegate responsibility to junior writers.

  • Expert ability to motivate and develop best in class talent pipeline.

  • Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.

  • Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.

    Preferred:

  • Master’s degree or PhD

  • Experience in Oncology/Lung Cancer drug regulatory writing

    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.

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Other Locations

North America-United States-Massachusetts, North America-United States-New Jersey

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105985167W

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