Clinical Pharmacology & Pharmacometrics Scientific Writing & Reporting Principal Scientist

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