ASSOCIATE DIRECTOR, EPIDEMIOLOGY AND REAL-WORLD DATA SCIENCES - MEDTECH

The Johnson & Johnson MedTech Epidemiology and Real-World Data Science team is recruiting for an Associate Director, Epidemiology & Real-World Data Science.
The primary and preferred locations for this position is Titusville, NJ.  Consideration may also be given for this position to be located in  New Brunswick, NJ, West Chester PA, Raynham, MA, Cincinnati, OH, or Horsham, PA.
  Remote work options in the US may be considered on a case-by-case basis and if approved by the Company.
The position reports to a Senior Director of MedTech Epidemiology & Real-World Data Sciences within the cross-sector Global Epidemiology Organization and the Office of the Chief Medical Officer.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through 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 humanity.
Learn more at https://www.
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Johnson & Johnson MedTech Companies have been working to benefit patients by improving surgery for over a century.
The MedTech Epidemiology and Real-World Data Science team is an industry leader in using real world evidence for medical devices and technologies.  We are driven by J&J’s Credo to benefit the patients we serve of all races, ethnicities, genders, and sexual orientation, to care for our employees, to benefit the communities and environment we work in and to work for the success our shareholders.
Our goal is to apply RWE as a tool to efficiently address the needs of J&J’s MedTech sector and to benefit patients.  To do this, we focus in 5 areas.
1) evidence for market access and adoption globally, 2) evaluations of product safety, 3) evidence for regulatory approvals (pre- and post-approval), 4) advancing the use of AI/ML use for MedTech, and 5) evidence for business development due diligence and identification of unmet needs.
This position is an exciting opportunity to lead safety-focused real-world data studies to support the generation of clinical evidence for post-market clinical follow-up activities to meet regulatory requirements, patient safety, and post-market surveillance.   The position requires good judgement in interpreting observational data to support regulatory decisions regarding patient safety.
Key Responsibilities.
You will actively partner with the Medical Safety, Medical Affairs, Scientific and Clinical Affairs, and R&D.
You will lead the design and conduct of epidemiologic studies using real world data to assess patient safety.
A priority focus is on RWE studies to meet regulatory requirements, particularly European Union Medical Device Regulation (EU-MDR) requirements for proactive surveillance.
You will write study protocols and study reports, use a variety of analytical techniques applied to various databases, and strategize regarding research programs.
You will leverage epidemiology methods to address emerging safety signals and queries.
You will assist in developing new safety surveillance methods in collaboration with J&J teammates.
You will communicate with and lead projects with regulatory agencies, such as the US Food and Drug Administration (FDA) and Notified Bodies in the EU.
You will participate in various activities of medical device businesses (DePuy Synthes, Ethicon, and Cardiovascular and Specialty Solutions), the larger cross-sector Epidemiology Department (Janssen Pharmaceutical and J&J Consumer) and the Office of Chief Medical Officer.
Qualifications A PhD or MD with at least 4 years of Epidemiology or related research work experience is required.
OR Master’s degree in Epidemiology, Health Services Research, Health Outcomes Research, Biostatistics, or other related field with at least 6 years of Epidemiology or related research work experience in health care is required.
Experience using a statistical programming language (e.
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SAS, R, SQL) is required.
Experience using healthcare databases, registries, observational study design is required.
Experience analyzing and interpreting quantitative data is required.
Experience writing epidemiology protocols and study reports is required.
Experience in cross-functional collaboration and working in matrix teams is required.
Epidemiology or related research work experience in Pharmaceutical or Medical Device and Diagnostics industries is preferred.
Experience in designing and conducting safety studies is preferred.
Experience working with regulatory authorities and/or European notified bodies is preferred.
Strong written and oral communication skills are required Experience authoring peer reviewed publications using real world datasets is preferred.
This position may require up to 15% of domestic and international travel.
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.  The anticipated base pay range for this position is $ to $.
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.
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits.
•           Vacation – up to 120 hours per calendar year •           Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year •           Holiday pay, including Floating Holidays – up to 13 days per calendar year •           Work, Personal and Family Time - up to 40 hours per calendar year  For additional general information on Company benefits, please go to.
- https://www.
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nj.
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For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
This job posting is anticipated to close on .  The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
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