Buisness Area: Clinical Solutions

Location: Natick, MA

Position Code: CSMDW2

Position Description

This position is full-time. (Part-time, contract, and contract-to-permanent candidates will be considered, depending upon experience.)

• Successfully support the Practice Leader in the execution of the clinical development programs in accordance with operating timelines, GCP-compliant Standard Operating Procedures, and other applicable SOPs and regulations
• Uphold processes that ensure the absolute integrity of clinical study data sets, analysis, and Clinical Study Reports
• Support the compilation, organization, and production of protocols, clinical study reports, IRB submissions, and other controlled documentation
• Support the development of meeting materials (presentations, posters, and abstracts) for internal and external review meetings
• Create technical documentation including: project plans, functional specifications, user interface requirements, system architecture and implementation, software requirements, validation testing, and user documentation
• Project a mature, professional image and provide responsive, meaningful, high-quality clinical operations support and follow-up to client and study site inquiries
• Maintain a daily clinical operations workplan and calendar that track important activities, milestones, and deadlines
• Maintain the requisite computer skills to effectively utilize state-of-the-art office equipment and systems (Ongoing testing and certifications may be expected)
• Understand and comply with Standard Operating Procedures and work instructions
• Perform other duties as may be assigned by the Senior Medical Writer and senior management
• Report to the Clinical Solutions Practice Leader

• Minimum 3 years successful scientific/medical writing experience with leading biomedical industry firms in the medical device, pharmaceutical, and/or contract research industries (Entry level candidates will be considered, depending upon experience.)
• Comprehensive understanding of harmonized GCP standards, the medical device product development and approval process, and HIPAA
• Strong, documented proficiencies in Good Clinical Practices and related Standard Operating Procedures
• Successful contributions to Class II and III regulatory submissions and approvals
• Undergraduate BS or BA degree in life sciences from a leading university (Candidates with relevant clinical experience will be considered, depending upon experience.)
• Certifications in Microsoft Windows and Office applications preferred
• Must be willing to relocate to the Boston area permanently, for up to 2 years
• Excellent presentation and communication (both oral and written) skills
• Excellent time management, planning, and teamwork skills
• Must be willing to work hours as needed to meet deadlines and needs

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