Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies (JJFC), is recruiting a Manager-Clinical Pharmacology to be located at its McNeil Consumer Healthcare Facility in Fort Washington, Pennsylvania.
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products.
The Manager Clinical Pharmacology will provide support to the global Consumer portfolio with a focus on medicinal products. In North America JJFC markets a broad range of well-known and trusted OTC medicines including TYLENOL® acetaminophen products, the leading brand of pain reliever/fever reducer in the adult and pediatric categories. BENADRYL® and ZYRTEC® allergy medicines; IMODIUM® anti-diarrheal products; MOTRIN® IB; SUDAFED® and SUDAFED PE® nasal decongestants. Globally JJFC markets medicinal products containing many of the same active ingredients (eg. CALPOL®, DOLORMIN®) in addition to other well-known brands including Nicorette®.
The Manager, Clinical Pharmacology is responsible for supporting clinical research activities for both new and marketed products in accordance with current GCPs, company standard operating procedures, FDA regulations, and ICH guidelines. The Manager, Clinical Pharmacology requires skills in in both oral and written communications and is responsible writing protocols, reviewing study data listings and study reports, assisting with NDA applications, and contributing to project or company teams when assigned.
Decisions and recommendations made by Manager, Clinical Pharmacology will have direct impact on delivery of programs, project schedules, cost and allocation of resources. In addition, this role is expected to be accountable for fostering internal collaboration and taking responsibility for key deliverables.
- Under supervision this position serves as a clinical pharmacology and pharmacokinetic content expert and has a broad range of responsibilities that include developing and prioritizing strategic, tactical, and participation in multiple matrixed research and development teams.
- Contribute to the planning and implementation of bioequivalence, pharmacokinetic, pharmacodynamic, and clinical studies conducted by JJFC to ensure adherence to Good Clinical Practices, high quality of data, and the appropriateness of study designs to meet both domestic and international requirements. This is accomplished by having advanced knowledge in the statistical and medical interpretation of study results, the ability to understand state-of-the-art computer and mathematical techniques that are used to analyze these types of data, and broad knowledge of regulatory requirements for drug development.
- Contribute to the preparation of submission documents to global regulatory agencies (.
- Work with cross-functional partners to establish project success criteria, monitoring project progress, and communicating information to management.
- Ensuring that clinical pharmacology requirements of markets are understood and incorporated upfront from product concept development. This helps ensure that products are developed in a way that will facilitate prompt regulatory approvals with competitive advantages in the intended markets.
- Partner with marketing and R&D organization to develop robust and innovative claims supported with sound science.
- Work with global/ regional/ local colleagues to provide support required to ensure projects can be aggressively implemented with greatest commercial impact.
- Participate in assessing new product opportunities and identifying requirements for projects under consideration, including evaluation of clinical pharmacology and clinical efficacy data owned by external organizations with regard to potential product acquisitions or partnering in product development.
Skills and Decision-Making:
- Ability to provide pharmacokinetic and modeling support to project teams working on new formulations and new products, as well as those supporting marketed products.
- Evaluate appropriate preclinical pharmacokinetic testing requirements and study designs to support developmental projects.
- Summarizing, analyzing and interpreting pharmacokinetic results in preparation for submission to regulatory agencies.
- Supporting new business development by assessment of new business opportunities.
- Support initiatives to establish strategies and processes to meet global requirements.
- Ensure quality and compliance with applicable policies, standard operating procedures, and regulations.
- Respond to regulatory authorities on pharmacokinetic and pharmacodynamic related questions and issues.
- Ph.D. in Pharmacology or PharmD with a minimum of 4 years of industry experience is required.
- Previous experience in OTC drug development, pediatric pharmacokinetics, and experience interacting with regulatory authorities is desirable.
- This position requires knowledge in drug metabolism, pharmacokinetics, pharmacodynamics, and clinical trial design, and knowledge of regulatory requirements for drug development.
- Ability to balance and prioritize based on short timelines and intense work volume while adhering to quality compliance requirements.
- Must be highly motivated and organized with excellent oral, written communication and effective presentation skills.
- The ability to work in a matrix environment with global cross-functional teams is essential.
- This position may require up to 10% annual travel both domestic and international.
United States-Pennsylvania-Fort WashingtonOrganization
J & J Consumer Inc. (6101)Job Function