Staff Clinical Research Scientist

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Job Function :

Discovery & Pre-Clinical / Clinical Development

Job Sub Function :

Clinical Development & Research – Non-MD

Job Category :

Scientific / Technology

All Job Posting Locations :

US052 OH Cincinnati - 4545 Creek Rd, US121 NJ Raritan - 1000 Highway 202 S

Job Description :

Johnson & Johnson MedTech is recruiting for a Staff Clinical Research Scientist located in Raritan, NJ or Cincinnati, OH.

Overall Responsibilities

On behalf of the MedTech Group, this clinical research professional will be responsible for the development of clinical evidence generation and dissemination strategies (EGS / EDS) across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects.

Key Responsibilities :

Under general direction and in accordance with all applicable federal, state and local laws / regulations and Corporate Johnson & Johnson, procedures and guidelines, this position :

Acts as a highly trained individual contributor involved in the design, execution, and / or reporting of clinical trials and or studies.

Analyzes the results of clinical research projects and drafts reports with detailed outcomes and results for relevant groups.

Leverages documentation needed for data collection, analysis, reviews and maintaining correct standard operations, procedures, and protocol.

Develops expertise and understanding of clinical trials documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies, and process.

Coaches more junior colleagues in techniques, processes and responsibilities.

Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Contribute to the development and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access)

Ensure input and strong alignment from key regional MD Clinical R&D leads and other strategically important countries / regions in the development of the EGS / EDS

Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal supervision

Plan for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures

Responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP)

Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders

Draft study reports with minimal supervision for assigned studies to include any annual reports, study close-out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions

Responsible for critically assessing the literature and drafting Clinical Evaluation Reports (CERs) for new products

Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections

Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, CSRs, and use of clinical data / evidence for market access and reimbursement

Foster strong relationships with key investigators to deliver evidence

Ensure registration on www.clinicaltrials.gov from study initiation through posting of results

Develop a strong understanding of the pipeline, product portfolio and business needs

Keep management informed of key developments and issues that impact clinical strategy and portfolio management

May be involved in other tasks to support clinical research activities as needed

Generally, manages work with limited supervision. Senior staff member may review work during development, dependent on level of complexity, and upon completion

Education & Required Skills / Experience :

• Bachelor’s Degree in Biological Science or related discipline with (6) years of relevant experience or a Master’s Degree in Biological Science or related discipline with (4) years of experience or a PhD in Biological Science or related discipline with (2) years of relevant experience

Required Skills & Experience :

Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations

Ability to provide scientifically strategic and scientific clinical research input across NPD and LCM projects

Proven track record in delivering clinical projects within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations

Ability to lead study teams to deliver critical milestones

Ability to collaborate across different functional areas within Clinical R&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.). and to meet business objectives

Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders

Leadership requirement – ability to influence, shape and lead without direct reporting authority

Other :

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 :

The anticipated base pay range for this position is [$125,500] to [$160,000]

Additional Description for Pay Transparency :

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)). This position is eligible to participate in the Company’s long-term incentive program. 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

Salary : $125,500 - $160,000