NONCLINICAL SUBMISSIONS WRITER, PRECLINICAL SCIENCES AND TRANSLATIONAL SAFETY

Johnson & Johnson is recruiting for Nonclinical Submissions Writer, Preclinical Sciences and Translational Safety to join our team located at our Spring House, PA site.
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.
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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Nonclinical Submissions 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 safety, pharmacokinetic, and discovery biology project leaders, medical writers, global regulatory dossier leaders, and other subject matter expert, to drive the integrated assessment of all nonclinical data in dossiers for submission to international regulatory health authorities.
In this role, the candidate will represent Preclinical Sciences and Translational Safety(PSTS) as the single point of contact on cross-functional global dossier teams and the Global Submissions Team on multidisciplinary departmental teams throughout drug development.
Key Responsibilities.
Lead in a team environment.
Work with a high level of independence and take a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
Plan, write, review, edit, and finalize nonclinical aspects of regulatory documents for compounds in development and marketed products, working across on multiple discovery and development projects in various therapeutic areas and modalities, including small molecules, large molecules, RNA modalities, gene therapies and cell therapies while representing nonclinical on cross-functional global dossier teams and coordinating writing activities and timelines.
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.
., DSURs, PBRERs, NDA annual reports), briefing documents, and responses to Health Authority questions.
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 To assure the overall quality and delivery of nonclinical contribution to submission dossiers, ensure compliance with regulations and adhere to best standard practices in nonclinical writing.
Participate in group initiatives related to document standards, template development, internal processes, and other aspects of document management.
Proactively provide recommendations for departmental process improvements.
Work efficiently in a global and matrix environment across different time zones Qualifications Education.
Minimum of Ph.
.
or equivalent level of experience in toxicology, pharmacology, drug metabolism and pharmacokinetics, or related biomedical/life sciences discipline with a minimum 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 and Skills.
Required.
Experience working globally as lead author on writing Toxicology, Pharmacology, Pharmacokinetics, or 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 preferred.
Expertise in multiple modalities, such as biologics and preferably ADCs.
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, along with flexibility, the ability to handle changing priorities, and stress resistant.
Proactive, sense of urgency, and able to excel within a matrix organization.
Critical thinker with excellent time management and delivery focus.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.