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

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmacokinetics & Pharmacometrics

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

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 a Clinical Pharmacology & Pharmacometrics Scientific Writing & Reporting Principal Scientist to be located in Spring House, PA; Raritan, NJ; or Titusville, NJ.

Purpose: The Clinical Pharmacology & Pharmacometrics (CPP) Scientific Writing & Reporting Principal Scientist is responsible for writing documents, coordinating reviews, performing document quality control (QC) and managing (e.g. timelines, resources, and metrics) CPP deliverables including but not limited to shell drafts of pharmacometric analysis and data transfer plans, pharmacometric memos and reports, and other types of CPP deliverables.

This role will also collaborate with cross-functional teams to streamline the coordination of consistent document uploads within the required regulatory document management system. Driving effective contributions to process enhancements including automation are key to this role. This function liaises closely with partners to ensure timely & high-quality delivery of documents, in line with applicable guidelines and regulations.

You will be responsible for:

• Writing and coordinating, shell draft, review, and/or final versions of CPP owned documents, including, but not limited to, analysis and data transfer plans based on study protocols, and various types of reports related to pharmacometrics and other types of analyses.
  
• Facilitating timely reviews and approval of written documents.
  
• Performing document QC of CPP deliverables and manage the review process, including timely documentation within the applicable document QC checklist, comment resolution follow up, lead document QC meeting in close collaboration with other colleagues within CPP, as required.
  
• Coordinating the central planning of document writing & QC of CPP deliverables, tracking project progress and support of metric reporting.
  
• Actively contributing to process improvements in support of interactions between Clinical Pharmacology & Pharmacometrics and cross-department partners.
  
• Supporting the development and maintenance of CPP reporting templates, analysis plans, summary documents, data transfer plans, as required in close partnership with the document service management group.
  
• Leading/contributing to process improvement and automation initiatives.
  
• Revising, updating and creating (if needed) SOPs, job aids, templates, training materials for CPP internal processes and other cross departmental processes as needs arise.
  
• Maintaining and applying knowledge of industry, company, and regulatory guidelines.

Qualifications / Requirements:

Education:

• A minimum of a Bachelor' s degree is required. An advanced degree (Master' s, PhD) is preferred.

Experience & Skills:

• 6+ years of pharmaceutical/scientific experience is required.
  
• At least 2 years of clinical writing experience is required.
  
• Good oral and written communication skills, including the ability to write and review cohesive reports and related documentation is required.
  
• Strong technical skills with MS Word is required.
  
• Knowledge of regulatory systems such as RIMdocs is required.
  
• General understanding of the overall process of drug development and clinical data is a plus.
  
• Attention to detail, proficient in time and project management skills are required.
  
• Ability to contribute to the organization assuming responsibility and accountability for successfully completing assignments or tasks is required.
  
• Ability to demonstrate learning agility is required.

Other:

• This position may require up to 5% of domestic and international travel.

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 08/03/2025. 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 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@ its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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