Hackensack Meridian Health
Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community. Together, we keep getting better — advancing our mission to transform healthcare and serve as a leader of positive change.
Overview The Medical Writer Clinical Trials is responsible for analyzing, writing and editing technical documentation summarizing clinical study ideas into protocols and resulting publications as well as writing summarizing other scientific matters. This role will contribute to developing and implementing comprehensive workflows and project planning to ensure ongoing clinical trial compliance across the Disease Specific Oncology Research Programs. This includes, but is not limited to, overseeing and driving the clinical research trials development and analysis process to final deliverables in a timely and effective manner. This role will collaborate and communicate with teams of investigators and research staff to ensure continual process development and improvement, always emphasizing clarity in training and implementation with the highest standards of integrity.
Responsibilities
Assist the principal investigator in the preparation of proposed clinical trials by developing trial protocols and associated documents, seeking input from all collaborating departments and ensuring the appropriate departments are notified and given a copy of the proposed trial feasibility, including scientific merit and accrual potential.
Collect and compile data, conduct analysis and summarize findings. Prepare manuscripts, abstracts, and reports for internal (marketing or product documentation) or external (regulatory submissions, medical journals, academic conferences or presentations) use.
Verify technical details of protocols and publications with medical or research personnel.
Review existing documentation for accuracy and clarification and make revisions as needed. Draft standard responses to common press or customer inquiries.
Handle basic issues and problems, and refer more complex issues to higher‑level staff.
Develop workflows for all aspects of study conduct for site staff and patients to ensure the highest quality work.
Oversee reports and assist with ongoing analysis of performance and workflows.
Provide efficient updates on progress with respect to assigned projects, project plans, trial and timeline management, and quality standards.
Ensure potential study risks are escalated to management as appropriate.
Implement solutions for streamlining and accelerating the development of Investigator Initiated Trials with an eye toward increasing accrual to clinical trials, data cleaning, data quality, and trial completion.
Provide regular reports regarding study progress and challenges and work with the PI to address any problems that arise.
Develop relationships and create points of contacts with new physician referral networks and pharmaceutical/biotech companies. Confer with health care professionals to determine the best recruitment practices for studies.
Maintain professional expertise through familiarity with therapeutic area and clinical research literature.
Oversee and drive projects from concept to final deliverables.
Work daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Regulatory Specialists, Contract Research Organizations, and employees of Hackensack Meridian Health.
Other duties and/or projects as assigned.
Adhere to HMH Organizational competencies and standards of behavior.
Qualifications
Bachelor’s degree in a scientific or medical discipline.
Minimum of five or more years of experience in a clinical healthcare environment.
Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations.
Strong attention to detail and customer service focus is required.
Excellent medical writing, communication, organizational, presentation, documentation, and interpersonal skills.
Ability to work independently, or in a team, and handle multiple deadline‑driven tasks in a dynamic environment is essential.
Review and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulations.
Mandatory education on human subject research and GCP (CITI Training and Certification).
Possesses beginning to working knowledge of subject matter.
Excellent written and verbal communication skills.
Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
Preferred Qualifications
Higher education degree (M.S., PhD, MD).
Knowledge of clinical trials and the regulation (local, state, and federal) of such.
Familiarity with basic scientific and healthcare principles and terminology.
Compensation & Benefits Minimum rate of $63.05 per hour. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. Compensation is benchmarked against market data to ensure competitiveness and is determined by factors such as experience, education, certifications, skills, geographic location, internal equity, and budget or grant funding.
In addition to our compensation for full‑time and part‑time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
EEO Statement HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good‑faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market‑competitive total rewards package.
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Overview The Medical Writer Clinical Trials is responsible for analyzing, writing and editing technical documentation summarizing clinical study ideas into protocols and resulting publications as well as writing summarizing other scientific matters. This role will contribute to developing and implementing comprehensive workflows and project planning to ensure ongoing clinical trial compliance across the Disease Specific Oncology Research Programs. This includes, but is not limited to, overseeing and driving the clinical research trials development and analysis process to final deliverables in a timely and effective manner. This role will collaborate and communicate with teams of investigators and research staff to ensure continual process development and improvement, always emphasizing clarity in training and implementation with the highest standards of integrity.
Responsibilities
Assist the principal investigator in the preparation of proposed clinical trials by developing trial protocols and associated documents, seeking input from all collaborating departments and ensuring the appropriate departments are notified and given a copy of the proposed trial feasibility, including scientific merit and accrual potential.
Collect and compile data, conduct analysis and summarize findings. Prepare manuscripts, abstracts, and reports for internal (marketing or product documentation) or external (regulatory submissions, medical journals, academic conferences or presentations) use.
Verify technical details of protocols and publications with medical or research personnel.
Review existing documentation for accuracy and clarification and make revisions as needed. Draft standard responses to common press or customer inquiries.
Handle basic issues and problems, and refer more complex issues to higher‑level staff.
Develop workflows for all aspects of study conduct for site staff and patients to ensure the highest quality work.
Oversee reports and assist with ongoing analysis of performance and workflows.
Provide efficient updates on progress with respect to assigned projects, project plans, trial and timeline management, and quality standards.
Ensure potential study risks are escalated to management as appropriate.
Implement solutions for streamlining and accelerating the development of Investigator Initiated Trials with an eye toward increasing accrual to clinical trials, data cleaning, data quality, and trial completion.
Provide regular reports regarding study progress and challenges and work with the PI to address any problems that arise.
Develop relationships and create points of contacts with new physician referral networks and pharmaceutical/biotech companies. Confer with health care professionals to determine the best recruitment practices for studies.
Maintain professional expertise through familiarity with therapeutic area and clinical research literature.
Oversee and drive projects from concept to final deliverables.
Work daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Regulatory Specialists, Contract Research Organizations, and employees of Hackensack Meridian Health.
Other duties and/or projects as assigned.
Adhere to HMH Organizational competencies and standards of behavior.
Qualifications
Bachelor’s degree in a scientific or medical discipline.
Minimum of five or more years of experience in a clinical healthcare environment.
Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations.
Strong attention to detail and customer service focus is required.
Excellent medical writing, communication, organizational, presentation, documentation, and interpersonal skills.
Ability to work independently, or in a team, and handle multiple deadline‑driven tasks in a dynamic environment is essential.
Review and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulations.
Mandatory education on human subject research and GCP (CITI Training and Certification).
Possesses beginning to working knowledge of subject matter.
Excellent written and verbal communication skills.
Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
Preferred Qualifications
Higher education degree (M.S., PhD, MD).
Knowledge of clinical trials and the regulation (local, state, and federal) of such.
Familiarity with basic scientific and healthcare principles and terminology.
Compensation & Benefits Minimum rate of $63.05 per hour. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. Compensation is benchmarked against market data to ensure competitiveness and is determined by factors such as experience, education, certifications, skills, geographic location, internal equity, and budget or grant funding.
In addition to our compensation for full‑time and part‑time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
EEO Statement HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good‑faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market‑competitive total rewards package.
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