Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
We are recruiting for a Principle Medical Writing Scientist in High Wycombe (United kingdom) or Titusville, NJ / Spring House, PA / Raritan, NJ in the USA.
Are you able to support our Oncology therapeutic area? You will be:
•Preparing and finalising scientific and clinical documents at the highest quality in terms of scientific content, inline with established timelines and processes
•Managing projects and deciding on strategies within processing/timeline constraints and appropriate deviations from normal practice to meet unusual challenges.
•You will provide mentorship to contractors, overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
•Collaborating while working in a team and taking a dedicated role on multiple assigned projects with respect to timing, scheduling, and tracking.
•Contributing scientifically and strategically and you may be leading submission-level, strategic activities for the writing team.
•you will dedicatedly identifying productivity opportunities and participate in finding flexible solutions.
•Negotiating with and influencing others with regard to scientific content / processes.
Do you have the following skills, experience and qualifications we are looking for?
•Bachelor’s degree / Masters Degree in a relevant discipline
•Experience in medical writing lasting at least 5 years?
•Strong scientific, medical writing skills including interpreting and organising scientific data.
•Experience writing clinical regulatory submission / safety documents, such as Clinical Study Reports, Investigator’s Brochures, Clinical Study Protocols, CTD Summary Documents.
•Experience in project managing and working on cross-functional teams
•In-depth knowledge of writing guidelines, such as ICH, FDA, AMA
•Knowledge of the end-to-end drug development process.
Does this sound like the opportunity for you? If so please click to apply.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)