Johnson & Johnson is recruiting for a Principal Scientist, CMC Regulatory Dossier Development which can be located in Spring House, PA; Horsham, PA; Malvern, PA; Raritan, NJ; Beerse, Belgium; Leiden, Netherlands; Cork, Ireland or Schaffhausen, Switzerland. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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 Principal Scientist, Dossier Development, with some managerial guidance, develops the technical eCTD sections for Regulatory CMC dossier applications, coordinating and providing the technical oversight for the generation of the CMC dossier for marketing and clinical trial submissions. Coordinates the timelines, virtual document, and Quality module generation while assuming ownership for business results and solutions. Represents the department on multi-functional project development teams to support regulatory filings and authors/drives sections of the CMC dossier ensuring compliance with regulatory requirements.
The Principal Scientist supports technical functions in developing responses to health authority inquiries for clinical trials and marketing applications, ensuring the completeness, accuracy and compliance of data provided for all regulatory submissions. Ensures timely completion of Quality submissions.
Key Responsibilities:
- Supports and implements dossier strategy/product development plans with autonomy.
- Manages project budgets and may lead dossier authoring activities for late-stage regulatory filings with some managerial support.
- Identifies and drives business improvements within the functional organization and collaborates with other departments as needed.
- Work with CMC/Tech team members, Regulatory, Janssen Supply Chain, external service providers and internal Discovery, Product Development and Supply customers such as Global Clinical Operations and Therapeutic Areas.
- Collaborate with internal and some external partners, influencing alignment on new ideas and approaches.
- Combine technical expertise with managerial skills and may manage consultants.
- Handle a limited number of standard projects or, with assistance, complex projects with accelerated priority.
- Challenges the status quo and identifies innovative process improvements.
- Make day-to-day operational decisions and allocates resources, while working independently and checking in weekly with a supervisor.
- Manages functional or project teams of up to 10 members.
Qualifications
Education:
- PhD with 3+ years of relevant post-doc experience OR Bachelor's or Master's degree with 6+ years of relevant experience is required.
Experience and Skills:
- Familiarity with CMC (Chemistry, Manufacturing, and Controls) regulatory submissions, eCTD format, and relevant regulatory guidelines (e.g., FDA, EMA) is preferred.
- Experience managing complex projects, preferably in the pharmaceutical or biotech industry, with a focus on regulatory submissions is preferred.
- Experience in writing or overseeing the preparation of regulatory documents, including CMC sections for marketing and clinical trial submissions is preferred.
- Experience collaborating with various departments and external partners in a multi-disciplinary environment is preferred.
- Ability to develop and implement strategic plans related to dossier development and product timelines is preferred.
- Skills in leading teams or projects, mentoring colleagues, and managing resources effectively is preferred.
- Excellent written and oral communication skills with the ability to communicate complex technical information to diverse partners is preferred.
- Strong analytical and problem-solving abilities to identify and implement business improvements and innovations is required.
- Ability to work independently, manage multiple priorities, and adapt to changing project needs is required.
The anticipated base pay range for this position is $115,000 to $197,800.
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.
This job posting is anticipated to close on 02/14/2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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.