Johnson & Johnson Innovative Medicine is recruiting for Expert RA Professional Submissions, Submission Management. The position can be located on-site/hybrid in the US (Titusville, NJ; Spring House, PA; Raritan, NJ) or Europe (Beerse, Belgium; High Wycombe, United Kingdom; Leiden, Netherlands; Allschwil, Switzerland).
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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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Expert RA Professional Submissions, Submissions Management collaborates with colleagues to ensure compliance with regulatory agency regulations and interpretation. This position coordinates and compiles dossier plans/submission packages and may publish/dispatch. The Expert RA Professional Submissions may be responsible for the management and delivery of HA submissions. Special projects may be assigned and reviewed periodically.
In this role, you will:
- Creates and manages the Dossier Plan(s)/Submission Packages for HA Submissions in line with clinical trials regulatory strategy. Seeks inputs from regulatory therapeutic areas, functional area representatives, and key stakeholders. Ensures that all required documents are included in the Dossier/Submission Package.
- Performs a dossier review of the published output.
- Tracks document status inside Dossier Plans with functional area owner.
- May lead submission team meetings. Works with partners to resolve issues (e.g., with time lines, document e-sub readiness, etc.).
- Monitors the effectiveness of the dossier process.
- Participates in special projects and process improvement initiatives, as needed. Supports development of departmental work practices, process enhancements / improvements, and associated training materials.
- May create and/or sign specific submission documents.
- Where appropriate, provides component-level publishing support for regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.).
- Utilizes regulatory information management systems and tools go across to compile and/or publish dossiers according to regulatory requirements for paper and electronic submissions.
Qualifications
- University/Bachelor's degree or equivalent experience and generally 4-6 years of pharmaceutical industry or related experience OR Masters/Pharm D or PhD with 0-2 years' experience is required.
- Experience with vendor and project management is preferred.
- Very good understanding of a clinical trial development process is required.
- Effective interpersonal, teamwork, and communication skills is required.
- Demonstrated ability to work or lead in a matrix environment is required.
- Fluency in English; other languages may be required depending on assignment is required.
- Ability to use Regulatory Information Systems planning tools and /or publishing tools is required.
- Demonstrated problem solving, trouble shooting, and adaptability is required.
- Knowledgeable of clinical trials submissions to HA and industry regulations and guidelines as relevant is required.
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.]
The anticipated base pay range for this position is 76000 to 121900.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
- Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.