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Regulatory Affairs Group

Lead Regulatory Scientist, Oncology

  • Título Lead Regulatory Scientist, Oncology
  • Función Regulatory Affairs Group
  • Sub función Regulatory Affairs
  • Categoría Senior Analyst, Regulatory Affairs (P6)
  • Ubicación Raritan, New Jersey, United States; United States; Spring House, Pennsylvania, United States; Malvern, Pennsylvania, United States; Horsham, Pennsylvania, United States; Titusville, New Jersey, United States
  • Publicado
  • [Close Date]
  • Identificación requerida (Req ID) 2406178298W
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This job posting is anticipated to close on abr. 13 2024. The Company may however extend this time-period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.

Descripción

Janssen Research and Development, LLC., a member of Johnson and Johnson's Family of Companies, is recruiting for a Lead Regulatory Scientist, Oncology . The preferred location is New Jersey or Pennsylvania. Other locations in the northeast U.S. may be considered on a case-by-case basis 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/ .

This position will support the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Oncology therapeutic area.

Key Responsibilities:

  • Participate in global regulatory team meetings and provide advice the applicable regulatory requirements, project-specific regulatory issues.
  • Build an understanding of the regional regulatory environment (relevant laws, regulations, guidance and competitive landscape) for assigned products.
  • Assist in strategy development by researching regulatory and medical information in preparing submissions to North American Health Authorities (HAs).
  • Assist in the preparation of HA meetings and act as back-up for contact with HA as needed.
  • Ensure responses to HA queries are made in a timely manner, and that content is consistent with the regulatory strategy.
  • Provide regulatory support throughout registration process and life-cycle management.
  • Work cross-functionally and lead team meetings as appropriate.
  • Review development plans, protocols and submission plans, ensuring alignment with regulatory requirements.
  • Support the development and improvement of processes related to regulatory submissions.
  • Stay on top of current and pending approvals in specific therapeutic areas and knowledgeable of laws, guidances and requirements related to those areas.

Calificaciones

Education:

  • Bachelor’s Degree in a scientific or equivalent subject area with 6 years of relevant industry experience or Master’s degree with 4 years of relevant experience, or PharmD/Ph.D. with 2 years of relevant experience is required.

Experience and Skills:

Required:

  • Previous regulated health industry experience is required.
  • Solid understanding of the drug development process and regulatory submission and approval processes is required.
  • Knowledge of US guidelines and practices in the regulatory environment is required.
  • Ability to work effectively within a cross-functional team and as an individual contributor is required.
  • Project management, oral & written communication skills, organization and multi-tasking skills are required.
  • Strong interpersonal and time management skills are required.
  • Demonstrated ability of critical thinking and contingency planning skills with respect to organizational or program objectives are required.
  • Effective critical thinking, including problem solving and goal setting for improved efficiencies is required.

Preferred:

  • Direct experience in regulatory affairs and/or Oncology drug development experience is preferred.
  • Regulatory, Clinical or R&D experience with products in early and late development stages is preferred.
  • Experience responding to FDA requests, handling HA interactions, and lifecycle management of regulatory applications is preferred.

Other:

  • Proactively anticipates issues; exercises judgment in developing new approaches/solutions and solving problems.
  • Influences or persuades others within area of immediate responsibility, scope and level to accept new insights, practices and approaches
  • May have interaction with internal and external colleagues with coordination between departments.
  • May represent J&J or company externally with some degree of supervision.
  • This position may require less than 10% travel.

The anticipated base pay range for this position is $104,000 to $166,750. 

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.
  • Work, Personal and Family Time - up to 40 hours per calendar year.

Additional information can be found through the link below.

For additional general information on Company benefits, please go to:  https://www.careers.jnj.com/employee-benefits .

This job posting is anticipated to close on 04/12/2024. 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 .

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