.Director, Regulatory Medical Writing, OncologyAt 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.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.Position SummaryThis 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.Principal ResponsibilitiesWorks closely with key functional stakeholders in the Oncology TA and Delivery Unit to drive RegMW strategy and tactics as needed to optimize ways of working.Leverages the strategy and direction of specific Disease Area Regulatory Medical Writing in line with RegMW, IDAR, GD, and TA-specific objectives.Oversees adequate resource planning, prioritization, and allocation to ensure programs and projects within the Disease Area are optimally supported.Ensures, with the RegMW Oncology TA Head, that the RegMW strategy and processes are clear towards all stakeholders by organizing clear and consistent communication around it.Able to represent RegMW department with decision-making authority in R&D business organization with guidance from TA/FA Head or Global Head of RegMW.Ensures timely and high-quality delivery of departmental deliverables.Leads the development and consistent implementation of RegMW processes
