Description

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 at our Beerse, Belgium, or Spring House, PA locations.

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, Nonclinical Submission Writer will prepare and review regulatory submission documents that summarize toxicology, safety pharmacology, drug metabolism, and pharmacokinetics studies. The successful candidate will collaborate closely with key stakeholders such as nonclinical project leaders, medical writers, global regulatory dossier leaders, to drive the integrated assessment of all nonclinical data in dossiers for submission to international regulatory authorities. In this role, you will represent nonclinical fields as the single point of contact on cross-functional global dossier teams and the Global Submissions Team on multidisciplinary departmental teams throughout development. You will contribute to the global nonclinical scientific community on regulatory submissions using heart, science, and ingenuity.

Key Responsibilities:

• Accountable for planning, writing, reviewing, editing, and finalizing regulatory documents for compounds in development and marketed products.
• Working efficiently in a global and matrix environment across time zones
• Closely interact with key interface partners (Global Document Specialists and Global FDA’s Standard Exchange of Nonclinical Data (SEND) managers) for preparation of submission ready components and to facilitate the completion and technical/scientific correctness of SEND data
• Partner with Nonclinical Safety, Drug Metabolism and Pharmacokinetics, Bioanalytical and Pharmacology Leads to author global regulatory documents and submissions, including, but not limited to, written and tabulated summaries for INDs, CTAs BLAs/NDAs/MAAs, Investigator's Brochures, annual updates to regulatory submissions (e.g., DSURs, PBRERs, NDA annual reports), briefing documents, and addressing Health Authority questions. organize scientific and management review of documents, address and discuss review comments.
• Work on multiple discovery and development projects across different therapeutic areas and modalities including small molecules, large molecules, RNA modalities, gene therapies and cell therapies.
• Represent nonclinical on cross-functional global dossier teams and coordinate writing activities and timelines.
• Accountable for assuring the overall quality and timely delivery of nonclinical contribution to i submission dossiers
• Participate in group initiatives related to document standards, template development, internal processes, and other aspects of document management.
• Ensure compliance with regulations and the best standard practices in nonclinical writing. Adhere to Janssen SOPs and work practices.

Qualifications

Requirements:

• Ph.D. or equivalent level of experience in toxicology, pharmacology, drug metabolism and pharmacokinetics, or related biomedical/life sciences discipline with at least 5 years of pharmaceutical/biotech/CRO industry experience working as study director/monitor, research scientist, or (nonclinical) writer is preferred. Candidates with BS or MS degree and additional years of relevant experience will also be considered.
• Experience working globally as lead author on writing Toxicology, Pharmacology Pharmacokinetics, Bioanalytical regulatory documents for submission to health authorities in major regions (US, EU, Asia).
• Excellent writing skills coupled with a good understanding of electronic submission requirements, GLPs, knowledge of regulatory requirements specific for nonclinical modules, ICH guidelines, FDA and EMA/CHMP regulations and guidelines, and other international regulatory requirements, attention to details and excellent verbal communication skills.
• Proven track record of success in planning and implementing nonclinical submission support in global regulatory submissions.
• Proven ability to interpret and present nonclinical data and facilitate issue/comment resolution as it relates to finalization of nonclinical submission documents Experience in executing on multiple and dynamic programs with competing and aggressive timelines in a matrix environment.
• Excellent interpersonal, organizational, oral/written communication and teamwork skills are required.
• Proactive, Sense of urgency
• Flexible, can deal with changing priorities and stress resistant.

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.