Johnson & Johnson Careers
Principal Medical Writing Scientist
Requisition ID: 1905756606W
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 Principal Medical Writing Scientist in High Wycombe in the United Kingdom.
Are you able to support our Oncology therapeutic area? You will:
- Prepare high quality clinical documents in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency. You will contribute scientifically and strategically to projects and project teams.
- Lead projects and drive strategies within processing/timeline constraints to meet unusual challenges. Lead submission-level, strategic activities for the writing team.
- Guide or train cross-functional team members, including external contractors, on processes and standard methodologies; coach or mentor more junior writers. You will lead the work of other medical writers, external contractors, and document specialists supporting a project.
- Collaborate while working in a team and take a dedicated role on multiple assigned projects with respect to timing, scheduling, and tracking.
Do you have the following skills, experience and qualifications we are looking for?
Minimum of a Bachelor’s degree in a relevant discipline
Experience in regulatory medical writing.
Strong medical writing skills including interpreting and organising scientific data
Experience writing clinical regulatory documents such as, but not limited to, Clinical Study Reports, Investigator’s Brochures, Clinical Study Protocols, CTD Summary Documents, health authority responses, briefing documents, and risk management plans
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, colour, 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)