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.

Learn more at https://www.jnj.com/.

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...