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Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Issy-les-Moulineaux, France, Madrid, Spain, Scoresby, Victoria, AustraliaJob Description:
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 https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Senior Principal Scientist, Investigational Product Preparation Strategy.
Purpose
Within the CMC Portfolio Strategy group, you will lead activities related to use of investigational products used in the conduct of clinical trials to ensure consistent program deliverables including the Investigational Product Preparation and Administration instructions (IPPI) across our diverse portfolio.
You Will Be Responsible For
- Creating the IPPI to ensure that best practices for IP preparation and administration are incorporated in our processes and look for opportunities to improve the process.
- Ensuring our approaches are consistent with clinical site research pharmacy and nursing practice to ensure patient safety in compliance with applicable regulations, international standards, good clinical practices, and institutional policies and procedures.
- Providing consultation and lend expertise across J&J Innovative Medicine to ensure the safe and accurate delivery of our portfolio at clinical sites and will be the CMC point of contact for IP preparation and administration.
- Contributing to the CMC portfolio management team tracking milestones for reporting to senior management.
- Seeking opportunities for team or product development improvements across the TDS organization. You may also support or lead teams in implementing initiatives to deliver organizational or process improvements.
- Demonstrating behaviors consistent with the current Leadership Imperatives and will be mentoring and coaching team member to improve their skills and contributions to the organization in collaboration with line management.
- Working in a multi-disciplinary, complex and innovative environment, delivering IP strategy and documents across Therapeutic Areas and the development process, including early, late and LCM development.
Education
Qualifications / Requirements:
- A Bachelor of Science in Nursing, Doctor of Pharmacy, or international equivalent is required
Required
- A minimum of 10 years recent experience in a patient care setting as a nurse or pharmacist with detailed knowledge of United States Pharmacopeia (USP) requirements for investigational agents is required
- Experience in implementing strategies for the safe and accurate delivery of investigational products in a clinical setting is required
- Extensive experience in the preparation and/or administration of both investigational and commercial agents is required
- Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills are required
- Excellent interpersonal skills with the ability to adapt effectively to a constantly evolving organization issues, structures and dynamics are required
- Demonstrated capability to manage multiple projects is required
- Ability to make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment to these decisions is required
- Influencing ability without line authority is required
- Active clinical license as a nurse or pharmacist is required
Required Skills:
Preferred Skills:
Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Collaborating, Data Synthesis, Drug Discovery Development, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Program Management, Scientific Research, Tactical Planning, Technical CredibilityJohnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
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