Director, Regulatory Medical Writing, Oncology

Director, Regulatory Medical Writing, Oncology

At 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/

Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, pulmonary hypertension, and retinal disease.

We are recruiting for a Director to join the Regulatory Medical Writing team to support the Oncology therapeutic area.

The position may be located in High Wycombe in the UK; Raritan or Titusville, NJ, or Spring House, PA in the US; Beerse, Belgium; Canada; or Leiden, Netherlands.

Other locations may be considered.

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!
Position Summary


* This position is accountable for setting the strategy and operational execution for the Prostate/Solid Tumor Targeted Therapy portfolio within the Oncology Regulatory Medical Writing team, in close consultation and accordance with the RegMW Oncology TA Head and in line with R&D priorities, Therapeutic Area objectives, and IDAR/GD strategic imperatives.


* Recognized expert medical writer for any documents within and across therapeutic areas.


* Partners in close collaboration with leadership across GD, the TAs, and the overall R&D organization to provide high quality deliverables successfully and efficiently.

Influences key senior stakeholders across these organizations to align on best strategies and tactics to deliver efficient and successful deliverable submission.


* Accountable for the Prostate/ST3 Disease Area medical writing resource management and allocation.


* Accountable for process compliance aspects for the sub-Therapeutic Area's work.


* Can represent the RegMW Oncology TA Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority.


* Can step in for the RegMW Oncology TA Head in case of absence.


* Contributes to and champions internal metrics, regulatory, and publishing guidelines as well as improvement of internal systems, tools, and processes.


* Works within the RegMW OLT to identify and promote cross-TA resource sharing and development opportunities.


* This position will report to the RegMW Oncology TA Head and will ensure the execution of the RegMW mission.

Principal responsibilities


* Works closely with key functional stakeholders in the Oncology TA...