Scientist, Trial Support

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmacokinetics & Pharmacometrics

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House Pennsylvania United States of America

Job Description:

We are searching for the best talent for our Scientist Trial Support position to be located in Spring House PA.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at The Scientist Trial Support position is a clinical operations support role within Bioanalytical Discovery and Development Sciences (BDDS). We work with internal bioanalytical groups and external partners to ensure the completion of all activities related to clinical study data deliveries and sample management. We work to support all therapeutic areas within Johnson & Johnson spanning non-clinical studies to post-market clinical development.

You will be responsible for:

• Acting as a developing individual contributor in the execution of pharmacokinetic/pharmacodynamics (PK/PD) research projects to support development programs and research of the properties of drug candidates.
• Contributing to studies supporting the discovery clinical candidate selection development and approval of medicines.
• Participating in the completion of all activities related to Global Bioanalytical Discovery & Development Sciences (BDDS) clinical and nonclinical study deliveries. At times assist with the completion of activities by other members of the group to ensure timelines are met.
• Partnering with Global Clinical Development Operations Integrated Data Analytics & Reporting (GCDO IDAR) BDDS Compliance & Data Integrity the Central Laboratory and the clinical trial teams when the bioanalytical sample management and data reporting requirements are established for a trial.
• Reviewing specifications documents from internal groups and Central Laboratories for studies where BDDS will be conducting analyses or reporting results.
• Defining studies in LIMS for clinical and nonclinical studies so that samples can be inventoried and analyzed.
• Delivering bioanalytical results to Global Clinical Development Operations Integrated Data Analytics & Reporting Translational Research with BDDS Global Clinical Pharmacology and/or CROs.
• Providing support with acquisition storage and disposition of clinical and nonclinical study samples.
• Generating status reports for sample data cleaning activities and issues relative to planned bioanalysis dates for multiple clinical studies and/or for multiple external service providers.
• Participating in process and system optimization projects.
• Coaching more junior colleagues in techniques processes and responsibilities.
• Understanding and applying Johnson & Johnsons Credo and Leadership Imperatives in day-to-day interactions with team.

Qualifications / Requirements:

• Bachelors degree with 3 years of relevant experience Masters degree with 2 years of relevant experience or a PhD with 1 year of relevant experience is required.
• Sample management experience is required.
• Basic understanding and experience reviewing lab-based technical documents (e.g. Protocols Statements of Work and/or Lab Manuals) is required.
• Experience working in database systems (e.g. Watson LIMS LabVantage LIMS etc.) is required
• Good communication skills and ability to communicate effectively across all levels of the organization required.
• Good organization attention to detail and time management skills required.
• Experience in areas of GLP/GCP is required.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check

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Required Skills:

Preferred Skills:

Analytical Reasoning Clinical Data Management Clinical Pharmacology Coaching Data Savvy Detail-Oriented Drug Discovery Development Pharmacokinetic Modeling Pharmacokinetics Pharmacometrics Process Chemistry Regulatory Environment Relationship Building Report Writing Research Documents Scientific Research Study Management Technologically Savvy

Required Experience:

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