Remote Trial Master File Jobs in Indiana (NOW HIRING)

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.jnj.com

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Epidemiology

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job 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 the role of Associate Director, Oncology Epidemiology. We have a preference for this position to be located in either Raritan, NJ 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 Associate Director, Oncology Epidemiology role is accountable for working independently, and in this role will also function under the supervision of more senior members of the department.

Primary responsibilities:

• Assist with identifying research study needs, drafting proposals and protocols, and contributing to epidemiology strategy and study conduct across the clinical development program.
• May conduct fit for purpose database and study feasibility assessments and execute analyses across the product cycle.
• Conduct literature reviews and synthesis; provide assistance to clinical teams with study design; and identify and evaluate data resources to meet therapeutic needs.
• Work closely with colleagues in the Observational Health Data Analytics group when defining research questions, developing epidemiological protocols, and implementing solutions.
• Provide epidemiological and/or statistical consulting, education and support to product teams, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature, as agreed by the team.
• Research natural history of diseases, both within and outside of existing electronic databases, to understand the inherent risks associated with the indication; statistical risk assessment; using historical clinical trial data and other observational databases to develop an understanding of potential safety issues for new medications, and indications, based on experience with related compounds.
• May work in cross departmental/sector committees, and or other efforts supporting J&J Innovative Medicine.
• Keep up to date with the FDA and other Regulatory Agencies regarding regulatory requirements for Post Approval Authorization Studies and Risk Management plans and the development of formal guidance for use of RWE for Regulatory Decision Making.

Qualifications:

• PhD in Epidemiology or a closely related field OR MD with training and degree in Epidemiology or a closely related field OR Master’s degree with at least 4 years of hands-on experience is required.
• At least 3 years of Epidemiology research experience is required.
• Must have an understanding and the ability to interpret quantitative methods.
• Experience with writing observational study protocols, proposals, and/or proposal requests, particularly the methods sections, is required.
• A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is required.
• Experience working with large administrative or medical records databases is preferred.
• Applied pharmacoepidemiology research is preferred.
• Background in epidemiologic material on specific diseases, conditions, or therapies particularly relating to Oncology therapeutic area is preferred.
• Experience working with health authorities is preferred.
• Phase III/IV medicine development experience is preferred.
• Experience working in a global environment is preferred.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is $137,000 to 235,750. 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 of Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

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.

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