What are the responsibilities and job description for the Medical Writer position at JMD Technologies Inc.?
Title: Medical Writer
Location: Boston, MA – Hybrid
Employment Type: Contract Accepting Candidates
About the Role
The Medical Writing Science Manager will prepare moderately complex clinical and regulatory documents and represent Medical Writing Science as a cross-functional team member at the clinical study level. This role contributes scientific knowledge and analytical skills to clinical regulatory documentation, with a strong focus on clinical development and the ability to summarize complex clinical and non-clinical data.
Key Responsibilities
Medical & Regulatory Writing
- Author moderately complex clinical regulatory documents, including clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions
- Serve as the lead Medical Writing Scientist for moderately complex clinical studies
- Participate in developing key messages for clinical regulatory documents
- Ensure medical and scientific consistency between related documents and studies within a clinical program
Clinical Data Analysis & Cross-Functional Collaboration
- Support the Medical Lead with review and interpretation of clinical study data
- Address questions from study team members
- Analyze and interpret data thoroughly and critically to determine the best approach to composing each document
- Summarize both clinical and non-clinical data into clear, succinct documents
- Contribute to product development plans by providing information from previous studies, scientific input, and integrated data review
- Serve as coordinating author for product development plans
Process & Project Management
- Work cross-functionally with key stakeholders and clinical study teams
- Participate in developing standard operating processes and related procedures
- Manage project teams, build productive working relationships, and work through conflicts
- Identify and contribute to improvements in cross-functional processes
Qualifications
- Ph.D. or equivalent degree required
- Typically 4 years of experience or equivalent combination of education and experience
- Clinical background or strong clinical knowledge
- Experience writing and editing clinical regulatory documents
- Experience with clinical study reports, clinical study protocols, and investigator’s brochures
- Ability to analyze, interpret, and summarize moderately complex data
- Strong understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
- Superior written and oral communication skills
- Excellent project management and organizational skills
Preferred Qualifications
- Strong experience supporting clinical development activities
- Experience creating succinct documents from extensive research data
- Ability to work effectively in highly cross-functional environments
- Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems
- Ability to work independently and develop alternative approaches to achieve desired results
- Initiative and creativity in solving routine problems affecting multiple documents and cross-functional processes
Compensation
- $55–$80/hr W2
- Boston, MA – Hybrid
- 6 Month Contract with potential for conversion to FTE
Salary : $55 - $80