At theJanssen Pharmaceutical Companies of Johnson & Johnson, what matters most ishelping people live full and healthy lives.
We focus on treating, curing andpreventing some of the most devastating and complex diseases of our time.
Janssen Research & Development, LLC discovers and develops innovativemedical solutions to address important unmet medical needs in oncology,immunology, neuroscience, infectious diseases and vaccines, and cardiovascularand metabolic diseases.
We are recruiting for a Principle Medical Writing at our high Wycombe UK site,you will be :
Preparing and finalising scientific and clinical documents at the highestquality in terms of scientific content, inline with established timelines andprocesses
Managing projects and deciding on strategies within processing / timelineconstraints and appropriate deviations from normal practice to meet unusual challenges.
You will provide mentorship to contractors, overseeing the work of othermedical writers, external contractors, and document specialists supporting aproject.
Collaborating while working in a team and taking a dedicated role on multipleassigned projects with respect to timing, scheduling, and tracking.
Contributing scientifically and strategically and you may be leadingsubmission-level, strategic activities for the writing team.
you will dedicatedly identifying productivity opportunities and participate infinding flexible solutions.
Negotiating with and influencing others with regard to scientific content / processes.
Do you have the followingskills, 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 andorganising scientific data.
Experience writing clinical regulatory submission / safety documents, such asClinical Study Reports, Investigator’s Brochures, Clinical Study Protocols, CTDSummary 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 thissound like the opportunity for you? If so, please click to apply.
Johnson & Johnson Family of Companies are equal opportunity employers, andall qualified applications will receive consideration for employment withoutregard to race, color, religion, sex, sexual orientation, gender identity,genetic information, national origin, protected veteran status, disabilitystatus, or any other characteristic protected by law