Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Medical Writing Specialist in the Titusville, New Jersey area, U.K., Europe, Belgium, Switzerland, or Canada. Remote work options may be considered, on a case-by-case basis and if approved by the Company!

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, hematology, immunology, neuroscience, infectious diseases, cardiovascular, metabolic, mental health, and pain management, and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

Position Summary:

• Able to write and coordinate basic and complex documents, independently when working within own TA, and under supervision when working across TAs.
• Leads in a team environment and matrix.
• Able to function as a lead MW on most compounds, under supervision.
• May actively participate in or lead process working groups.
• Provides input into functional tactics/strategy (eg, writing teams, process working groups).
• Highly proficient in the use of internal systems, tools, and processes.Principal Responsibilities:
• Writes or coordinates clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Leads cross-functional (eg, with clinical team) document planning and review meetings. Interacts 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.
• Completes all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
• Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision. Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
• Coaches or mentors more junior staff on document planning, processes, and content. Provides peer review as needed.
• May actively participate in or lead process working groups.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

Education and Experience Requirements:

• A university/college degree is required. An advanced degree (eg Masters, PhD, MD) is preferred.
• At least 6 years of relevant pharmaceutical/scientific experience is required.
• At least 4 years of relevant clinical/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 complex document types under general supervision.
• Excellent oral and written communication skills.
• Attention to detail.
• Ability to function in a team environment.
• Organizes time well.
• 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.
• Demonstrates learning agility.
• Builds solid and productive relationships with cross-functional team members.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

PRIMARY LOCATION

United States-Pennsylvania-Spring House-Welsh & McKean Roads

OTHER LOCATIONS

North America-Canada

ORGANIZATION

Janssen Research & Development, LLC (6084)

JOB FUNCTION

R&D

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.