Project Physician, Neurosciences Clinical Development
- United States
Janssen Research and Develop is recruiting for a Project Physician, located remotely in the US.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Project Physician (also known as a Study Responsible Physician) is a core member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of an innovative compound program in Phase 3. The Project Physician provides medical and scientific contribution to a cross-functional clinical team. The Project Physician provides input to the clinical development plan, works on the development of the trial protocol and materials, and takes ownership for the content of clinical study reports and documents for regulatory filings. Team interactions include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business areas. The Project Physician may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.
Key Responsibilities: Essential functions:
- Responsible for medical monitoring/reporting and company safety officer activities
- Works on clinical development plans, trial protocols, and takes ownership of reports
- Evaluates adverse events (pre and post-marketing) for relationship to treatment
- Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting
- May act as a medical contact at the company for health authorities concerning clinical/medical issues
- Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
- Close interactions with Project Scientists and Physicians across programs
- Helps explore and evaluate new product ideas to assist in identifying new market opportunities
- May work on consortium projects with other companies, foundations, and government organizations on pre-competitive topics.
- Support Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
- Reviews medical literature and related new technologies
- May be asked to assess medical publications emerging from the Team and its affiliates
- May be responsible, for review of Company advertising and promotional materials.
- Minimum of Masters' Degree with 5 years of experience or MD/PhD with appropriate residency training and certification with at least two years of experience in CNS clinical research.
- At least two years of experience with the conduct of clinical trials, preferably in CNS disorders
- Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
- Working knowledge of the use of Microsoft suite of software products including Excel and Word
- Experience in the pharmaceutical or biotechnology industry
- Experience in the design and conduct of psychiatry trials
- Board certification in a relevant field
- Medical license
English language proficiency
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.
United States-New Jersey-Titusville-
United States, Switzerland-Basel-City-Basel, Belgium-Antwerp-Beerse
Janssen Research & Development, LLC (6084)
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