Johnson & Johnson Careers

Senior Scientist, Non-Clinical Writer

Raritan, New Jersey
Toxicology Research


Job Description

Requisition ID: 8178190222

Janssen Scientific Affairs, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, Non-clinical Submission Writer to be based in Raritan, NJ
 
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.  
 
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
 
The Senior Scientist, Non-clinical Submission Writer will prepare and review regulatory submission documents that summarize toxicology, safety pharmacology, and pharmacokinetics studies. You will support nonclinical project leaders and collaborate closely with medical writers and global dossier leaders to drive the integrated assessment of all nonclinical data in dossiers for submission to international regulatory authorities. You will represent NCS as the single point of contact on cross-functional global dossier teams. Key responsibilities include:
  • You will support the nonclinical toxicology and DMPK project leaders on preparation of regulatory submission dossiers
  • In collaboration with project leaders, you are accountable for planning, writing, reviewing, and finalizing regulatory documents for compounds in development and marketed products
  • You will contribute to global regulatory documents that include written and tabulated summaries for INDs and BLAs/NDAs/MAAs, Investigator's Brochures, annual updates to regulatory submissions (e.g., DSURs, PBRERs, NDA annual reports), briefing documents, and regulatory agency response documents
  • Represent NCS on cross-functional dossier teams and lead writing activities including timelines and document preparation/review/revision
  • Responsible for assuring the overall quality and timely delivery of nonclinical submission dossiers
  • Participate in group initiatives related to document standards, template and processes development, and other aspects of document management
  • Ensure compliance with regulations and the best standard practices in medical writing

Qualifications
  • You will have a B.S. in toxicology, pharmacology or related biomedical discipline with at least 15 years pharmaceutical/biotech industry experience or M.S. with at least 10 years of experience
  • Excellent writing skills coupled with comprehensive knowledge of electronic submission requirements, GLPs, ICH guidelines, FDA and EMA/CHMP regulations and guidelines, and other international regulatory requirements
  • Proven ability to interpret and present nonclinical data and facilitate issue/comment resolution as it relates to finalization of nonclinical writing deliverables
  • Proven track record of success in planning and implementation of preclinical submission support in global regulatory submissions
  • Experience in leading multiple and dynamic programs with competing and aggressive time lines
  • Leadership experience (connecting, crafting, mentoring, leading, delivering) in a matrix environment
  • Strong written and oral communication skills
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.

Primary Location
United States-New Jersey-Raritan-
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Toxicology Research
Requisition ID
8178190222