Do you have the following skills experience and qualifications we are looking for
Bachelors 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 Investigators Brochures Clinical Study Protocols CTD Summary Documents.
Experience in project managing and working on crossfunctional teams
Indepth knowledge of writing guidelines such as ICH FDA AMA
Knowledge of the endtoend 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
At the Janssen Pharmaceutical Companies of Johnson & Johnson what matters most is helping people live full and healthy lives. We focus on treating curing and preventing some of the most devastating and complex diseases of our time.
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 submissionlevel 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.
Required Experience:
Staff IC