Senior Manager, Regulatory Medical Writing
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 and follow us @JanssenGlobal. Janssen Research & Development, LLC. is part of the Janssen Pharmaceutical Companies.
We are recruiting for a Senior Manager, Regulatory Medical Writing supporting the Oncology Therapeutic Area in Spring House, PA / Titusville, NJ / Raritan, NJ in the USA, or High Wycombe in the United Kingdom.
As a Senior Manager, Regulatory Medical Writing, you will:
- Prepare high quality clinical documents in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency. You will contribute scientifically and strategically to projects and project teams.
- Lead projects and drive strategies within processing/timeline constraints to meet unusual challenges. Lead submission-level, strategic activities for the writing team.
- Lead and develop a team of internal medical writers (direct reports).
- Actively participate in resource management and provide input into resource allocation and hiring decisions.
- Guide or train cross-functional team members, including external contractors, on processes and standard methodologies; coach or mentor more junior writers. You will lead the work of other medical writers, external contractors, and document specialists supporting a project.
- Collaborate while working in a team and take a dedicated role on multiple assigned projects with respect to timing, scheduling, and tracking.
- Minimum of a Bachelors degree plus 10 years relevant pharmaceutical/scientific experience (industry or academia), OR Masters degree plus 8 years of relevant pharmaceutical/scientific experience (industry or academia) is required.
- At least 8 years of regulatory medical writing experience is required.
- People management/leadership experience is highly preferred.
- Strong medical writing skills including interpreting and organizing scientific data are required.
- Experience writing clinical regulatory documents is required. Examples may include, but are not limited to, clinical study reports, clinical study protocols, investigator’s brochures, clinical summary documents, regulatory responses, and briefing documents.
- Experience in project managing and working on matrixed teams is required.
- In-depth knowledge of writing guidelines, such as ICH, FDA, AMA is required
- Knowledge of the end-to-end drug development process is required.
- Experience influencing senior leaders/stakeholders is highly preferred.
- This position may be located in Spring House, PA, Titusville, NJ, or Raritan, NJ in the USA, or High Wycombe in the United Kingdom, and may require up to 10% domestic travel.