Sr RA Professional Submissions

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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

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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 Sr RA Professional Submissions for Clinical Trial Applications to be in Leiden, NL or Warsaw, PL.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

High Wycombe, United Kingdom – Requisition Number: R-021191

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose:

As a Sr RA Professional Submissions for Clinical Trial Applications, you will collaborate with colleagues to ensure compliant and timely submissions to Health Authorities worldwide through the entire lifecycle of the clinical trial. You will coordinate and compile dossier plans and submission packages as well as ensure tracking and communication of submission and approval dates. Additionally, you may lead and/or contribute to special projects and participate in process improvement initiatives.

You will be responsible for:

• Dossier Management : Create and manage Dossier Plans and Submission Packages, ensuring compliance with regulatory strategies and necessary document inclusion.
• Review and Tracking : Conduct dossier reviews and track document statuses in collaboration with functional area owners.
• Meeting Leadership : Lead Clinical Trial Working Group Meetings and help resolve issues related to timelines and document preparedness.
• Process Improvement : Monitor the effectiveness of the dossier process and participate in special projects to enhance departmental work practices.
• Document Creation/Support : Create and sign submission documents, providing component-level publishing support for regulatory deliverables.
• System Utilization : Utilize regulatory information management systems for compiling and publishing dossiers according to submission requirements.

Qualifications / Requirements:

• University/Bachelor’s degree or equivalent experience with 4-6 years in the pharmaceutical industry or related field.
• A Masters/Pharm D or PhD is a plus
• Fluency in English; other languages may be required depending on assignment.
• Effective interpersonal, teamwork, and communication skills.
• Strong understanding of the product development process.