Staff Clinical Research Scientist - Mentor
The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Staff Clinical Research Scientist aligned to Mentor, located in Irvine, CA. The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics. Learn more about Mentor at www.mentorwwllc.com
On behalf of the Medical Device 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.
The Staff Clinical Research Scientist will:
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.
Be 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.
Critically assess 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.
Be involved in other tasks to support clinical research activities as needed.
Manage work with limited supervision. Senior staff member may review work during development, dependent on level of complexity, and upon completion.
Understand 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;
Provide scientifically strategic and scientific clinical research input across NPD and LCM projects;
Have a proven track record in delivering clinical projects within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations;
Have ability to lead study teams to deliver critical milestones;
Have 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;
Demonstrate ability to build collaborative relationships with key internal and external partners and stakeholders;
Have ability to influence, shape and lead without direct reporting authority
A minimum of a Bachelor's Degree with at least 6 years of clinical or related technical experience is required.
A Master's degree or PhD/MD/PharmD is preferred.
A Life Science, Physical Science, Nursing, or Biological Science degree is preferred.
Knowledge of Good Clinical Practices is required.
Understanding and application of regulations and standards applied in clinical areas is required.
The ability to influence others along with strong written and oral communication skills is required.
Advanced project management skills with the ability to handle multiple projects are preferred.
Medical device experience is preferred
Relevant industry certifications are preferred (i.e., CCRA, RAC, CDE).
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics. Learn more about Mentor at www.mentorwwllc.com
On behalf of the Medical Device 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.
The Staff Clinical Research Scientist will:
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.
Be 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.
Critically assess 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.
Be involved in other tasks to support clinical research activities as needed.
Manage work with limited supervision. Senior staff member may review work during development, dependent on level of complexity, and upon completion.
Understand 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;
Provide scientifically strategic and scientific clinical research input across NPD and LCM projects;
Have a proven track record in delivering clinical projects within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations;
Have ability to lead study teams to deliver critical milestones;
Have 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;
Demonstrate ability to build collaborative relationships with key internal and external partners and stakeholders;
Have ability to influence, shape and lead without direct reporting authority
A minimum of a Bachelor's Degree with at least 6 years of clinical or related technical experience is required.
A Master's degree or PhD/MD/PharmD is preferred.
A Life Science, Physical Science, Nursing, or Biological Science degree is preferred.
Knowledge of Good Clinical Practices is required.
Understanding and application of regulations and standards applied in clinical areas is required.
The ability to influence others along with strong written and oral communication skills is required.
Advanced project management skills with the ability to handle multiple projects are preferred.
Medical device experience is preferred
Relevant industry certifications are preferred (i.e., CCRA, RAC, CDE).
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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