Medical Writer

Technical Resources International, Inc.; Bethesda (MD); Hybrid; USD 70,000 - 85,000; Full time

Job summary

Technical Resources International, Inc. is seeking a Medical Writer in Bethesda, MD to prepare regulatory documents for FDA submissions and scientific reports.

The role involves literature reviews, data analysis, and contributing to technical proposals while maintaining QA processes. The position combines 2 days onsite at TRI's Bethesda office with 3 days of remote work, offering collaboration with IT and regulatory teams and opportunities to advance digital transformation and process

Qualifications

• Superior writing skills with strong English grammar and scientific writing proficiency.
• Knowledge of regulatory requirements for clinical studies and clinical research.
• Ability to solve problems and complete tasks with minimal oversight.
• Proficient in Microsoft Office and reference management software.
• Excellent time management, multi-tasking, attention to detail, and interpersonal skills.
• Experience analyzing medical research data and reviewing experimental protocols.
• Mentors and guides junior staff.
• Experience collaborating with IT or technical teams on digital transformation, automation, AI, or process improvement.

Responsibilities

• Prepares scientific and regulatory documents for FDA submissions and other regulatory documents.
• Performs literature searches or summarizes results.
• Prepares meeting reports and safety documents or data analyses.
• Contributes to technical proposals and responds to technical questions.
• Develops and maintains QC procedures to ensure timely, high-quality work products.
• Tracks progress on tasks and projects.
• Maintains document templates for annual reports, New INDs, etc.
• Assists in evaluating processes to identify opportunities for digitization, automation, AI, and workflow optimization to ensure compliance.

Skills

Superior writing

Regulatory knowledge

Problem-solving

MS Office

Time management

Data analysis

Mentoring

IT collaboration

Education

Master's Degree

Job description

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Job Title

Medical Writer

Location

Bethesda, MD 20817 US (Primary)

Category

Medical Writing

Job Type

Full-Time

Salary Range

70,000.00-85,000.00/YEAR

Education

Master's Degree

Travel

None

Job Description

• Prepares scientific and regulatory documents on behalf of government and private sector clients for submission to the Food and Drug Administration (FDA) (Investigational New Drug applications, annual reports and development safety update reports, preclinical and clinical study reports, safety reports, protocols and protocol amendments, and investigator’s brochures, etc.).
• Performs literature searches and/or prepares summaries of results.
• Prepares meeting reports and proceedings, safety documents or data analysis.
• Contributes to technical proposals and responds to technical questions.
• Develops and maintains quality control procedures to ensure processes are followed and timely and high-quality work products are delivered to clients.
• Tracks progress on tasks and projects.
• Maintains applicable templates for documents such as annual reports, New INDs, etc.
• Assists in evaluating existing processes and workflows to identify opportunities for digitization, automation, use of AI, and process optimization to ensure compliance with applicable clinical trial regulations, streamline efforts, and enhance quality.

Job Requirements

• Superior writing skills that require moderate to minimal editing (excellent English and grammar skills and demonstrated proficiency in scientific writing).
• Knowledge of regulatory requirements for clinical studies and a demonstrated interest in clinical research, medical writing, and/or regulatory affairs.
• Ability to problem-solve and complete tasks with minimal oversight.
• Strong software skills to include Microsoft Office products and reference management software.
• Excellent time management, multi-tasking skills, attention to detail, and interpersonal skills.
• Ability to analyze medical research data and review experimental protocols.
• Mentors and guides junior staff
• Experience collaborating with IT or technical teams on digital transformation, workflow automation, AI, data analytics, or process-improvement initiatives is a plus.
• This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.