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.