Medical Writer Clinical Trials

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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.

• 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.

• 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…