Johnson & Johnson, is recruiting for an Established Products (EP) Physician Fellow to be located in Titusville, NJ.
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The Established Products (EP) Physician Fellow is an associate member of the EP Clinical and Medical Team assigned to a one-year term (may be extended to include a second year of fellowship) rotating through multiple functional groups within EP within J&J Innovative Medicine.
The goal of the fellowship is to (1) develop leadership, clinical, and medical technical skills in drug development and life-cycle management and (2) gain an understanding of the role of a physician in a pharmaceutical company.
The EP Physician Fellow is assigned to Therapeutic Area Portfolio(s) and supports the Clinical and Compound Development Teams (CDTs) to maximize the value of the portfolio(s). The EP Physician Fellow will be a valuable colleague to work with the extended EP community through rotations with the Clinical, Medical Safety, Medical Affairs and Regulatory Affairs teams.
The fellow will spend up to 70% of their time working with functional coordinators and rotation mentors during each of their 15-weeks functional rotations (except Regulatory rotation which will be a 3-week rotation). In parallel, the fellow will divide the remaining time working with the assigned portfolio(s) on key assigned projects (20%), engaging in activities led by EP Talent Development Team (5%), and establishing connectivity and network-building opportunities with JNJ stakeholders (5%).
At the end of the third rotation and in alignment with the fellowship supervisor, the fellow will indicate their desire and interest to apply for a second-year extension of fellowship with a focus on up to two functional areas (6-month rotation each). The goal of the extension would be to gain additional practical experience and to complete clinical/medical projects as needed. Rotation coordinators and fellowship supervisor will assess candidacy for second year based on business needs and fellow performance and will communicate accordingly to fellow in order to plan for next steps to ensure a smooth transition into second year fellowship or off-fellowship to a permanent employment.
Roles and responsibilities:
- Achieve an overall understanding of how EP is structured/works and how it fits into the overall JNJ Innovative Medicine/OCMO organization.
- Complete the required compliance functional trainings as appropriate for an interim member of the EP Clinical & Medical Team.
- Ensure a clear understanding of the overall goals and objectives of EP's organization.
- Clinical:
- Contribute to the execution of projects across different phases of clinical development.
- Provide active medical and scientific contribution to cross-functional clinical teams.
- Support successful completion of clinical projects and deliverables that enable worldwide registrations for new indications.
- Complete enhancements to the label and compliance with regulatory commitments for products in the market and in development.
- Support innovative development projects to further enhance the value of our products and the EP organization to JNJ and the patients we serve. Work with the Clinical, Medical Affairs and Medical Safety Leaders, project management leads and extended CDT and their internal/ external partners in the execution of specific tasks and projects related to clinical studies and other tactical strategic activities conducted for the support of the assigned portfolio.
- Work in concert with the Clinical Leaders on clinical trial concept and protocol development, execute clinical studies for new formulations, post-approval commitments, and new indications.
- Be actively involved in creation of Clinical Study Reports (CSRs), publication of clinical research findings and presentations to relevant FDA, EMA, or other Health Authorities, advisory committees, and review meetings.
- Work with Medical Safety, Medical Affairs, Regulatory Affairs rotation coordinators and their functional teams to learn and get experience in multiple sub-functional areas of responsibility to broaden the fellow's understanding of the role of a physician in the pharmaceutical industry in a late lifecycle stage of the portfolio of products.
- Participate in cross-functional teams for evaluation of new product ideas and related innovative technologies; review medical literature, medical and market access plans.
- Medical Safety:
- Participate and complete training in several areas of pharmacovigilance, which include the following: safety surveillance and signal evaluation; identification of new potential safety concerns; characterization of emerging and known product safety profiles; the design and implementation of risk minimization strategies.
- Provide medical expertise in the evaluation of safety data from a variety of sources (interventional and noninterventional clinical studies, post-marketing data, literature reports, and other sources of safety data) as part of the overall pharmacovigilance surveillance process; this includes medical review of individual case safety reports (ICSRs) and evaluation of aggregate safety data.
- Gain understanding of Medical Safety Officer (MSO) activities. Ensure communication of potential new safety concerns and trends to the MSO and the Safety Management Team (SMT).
- Support SMT activities such as the evaluation of safety issues to characterize any emerging or known product safety profiles, preparation of aggregate safety reports, such as Periodic Benefit Risk Evaluation Reports (PBRERs), ad-hoc regulatory reports, and interpretation of surveillance and product quality data.
- Medical Affairs:
- Gain an understanding of the structure and function of the EP Global Medical Affairs organization
- Gain an understanding of core strategic Global and Regional Medical Affairs activities including evidence generation, evidence communication, internal knowledge transfer, thought leader engagement, pre-approval access, and patient safety.
- Gain an understanding of MAF role in key partnerships (CDT, GMAT/regional MAF leads).
- Regulatory Affairs:
- Gain an understanding of the structure and function of the Global Regulatory Affairs organization.
- Gain an understanding of the essential role of regulatory affairs in the matrix management of pharmaceutical products.
- Gain insight into regulatory strategy and decision-making and understand key aspects of regulatory affairs specific to each region.
- Perform related duties as assigned by supervisor.
- Maintain compliance with all company policies and procedures.
Qualifications
Minimum Qualifications:
- Must have a Medical Degree (MD/DO or equivalent).
- Must have at least 2 years of patient care/clinical postgraduate practice experience.
- Medical specialty residency and fellowship training is desirable. Board certification/eligibility is a plus.
- Training and/or experience in clinical research, epidemiology and/or public health is a plus.
- Must have a patient-centric mindset, scientific and medical acumen, intellectual curiosity, and excellent analytical skills to identify gaps, root causes, and to develop solutions.
- Must be able to work independently with limited supervision to meet deadlines.
- Must be able to effectively handle multiple priorities.
- Must have the ability to critically evaluate data from multiple sources (clinical trials, literature, etc.), assess clinical importance and potential impact of the data, and present the findings clearly in both written and oral communications.
- Excellent verbal and written communication skills including formal presentation skills.
Other requirements:
- Excellent computer proficiency (including MS Office: Word, Excel, PowerPoint, Outlook).
- Interest in pursuing a career in Pharmaceutical Industry.
- International Medical Graduates (MD/DO equivalent) are eligible.
The anticipated base pay range for this position is $133,000 to $230,000.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
https://www.careers.jnj.com/employee-benefits
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.