At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.Learn more at https://www.jnj.com
Job Function
Medical Affairs Group
Job Sub Function
Medical Writing
Job Category
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description
Senior Analyst, Medical Writing, Immunology
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Senior Analyst, Regulatory Medical Writing, within Integrated Data Analytics & Reporting (IDAR), to join our diverse team of medical writers for immunology indications. The role is located High Wycombe, United Kingdom (hybrid preferred). Remote work options may be considered on a case-by-case basis and if approved by the company.
Are you ready to join our team? Then please read further!
You Will Be Responsible For
* Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
* Leading cross-functional document planning and review meetings. Interacting with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
* Actively participating in or leading process working groups.
* Coaching or mentoring more junior staff on document planning, processes, and content. Provides peer review as needed.
Principal Relationships
* Internal: manager, other writers cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of clinical documents.
* External: May interact with or oversee day-to-day work by contractors or external service providers as needed under supervision. May collaborate with external partner company staff on codeveloped compounds.
Qualifications / Requirements
* A university/college degree in a scientific field is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
* At least 6 years of relevant pharmaceutical/scientific experience including at least 4 years of regulatory medical writing experience is required.
Other
* Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in all document types under general supervision.
* Proficiency in written and spoken English is essential, together with excellent oral and written communication skills.
* Strong attention to detail.
* Ability to collaborate with cross-functional global teams across time zones, requiring some flexibility in your daily routine.
* Builds productive relationships with cross-functional team members.
* Has strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision.
* Organizes time well, and demonstrates learning agility.
While we have a preferred candidate for this position, we welcome applications from all qualified individuals.
Benefits
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr