Johnson & Johnson Careers
Senior Scientist - preclinical writer
Requisition ID: 1905750847W
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, Nonclinical Submission Writer, within Nonclinical Safety (NCS) to be based in Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops creative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com for more information.
Growing with a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Scientist, Preclinical Writer will prepare and review regulatory submission documents that summarize toxicology, safety pharmacology, and pharmacokinetics studies. You will collaborate closely with nonclinical project leaders, 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.
- 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 (eg, 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.
- You will have a B.S. in toxicology, pharmacology or related biomedical discipline with at least 8 years pharmaceutical/biotech industry experience or M.S. with at least 4 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.
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